Pharmaceutical quality control jobs in New York, New YorkCreate job alerts

Job Description Ingenus Pharmaceuticals offers a generous Paid Time Off policy, as well as, 14 paid holidays per year. Medical, Dental and Vision benefits are offered to all associates and are effective on the 1st day of the following month after hire. Enrollment in 401k after 90 days. The Manufacturing Operator/Technician II is responsible for all functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. Major Areas of Responsibility  Execute Batch Record and logbook documentation with clear details and accuracy.  Execute the procedures used to clean pharmaceutical production equipment and facilities.  Operates pharmaceutical production machinery and executes procedures for manufacturing such as dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing etc.,  Executes total changeovers and cleaning.  Identifies and assists in the corrective actions of processing related issues.  Maintains production reporting for assigned work unit operation.  Performs required in-process product quality checks and document accurately.  Execute procedures to complete tasks in a safe, compliant and efficient manner.  Works in collaboration with others as part of a team.  Assists with on the job training of other production trainees and operators.  May determine methods and procedures on new assignments and may provide assistance to other support personnel.  Effectively communicates issues to supervisor.  Adheres to all cGMPs, compliance/regulatory mandates and quality requirements.  Assists in the identification and implementation of continuous improvement opportunities.  Performs other related duties as assigned to meet departmental and Company objectives. Required Knowledge, Skills and Abilities  Knowledge of Metric and English weighing and measurements systems.  Basic understanding of mechanical machinery and the operating principles of control systems.  Demonstrated mathematical ability in addition, subtraction, multiplication, division, ratios and percentages.  Ability to use a calculator.  Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation.  Accurate and precise in recording data and batch information.  Ability to work in both independent and team environments.  Proficient in reading and writing English to understand work instructions and document results.  Ability to operate pharmaceutical processing equipment.  Ability to meet required standards of cGMPs.  Demonstrated understanding of the unit operations and the ability to assist with on-the-job training of manufacturing trainees and operators. Education and Experience  High school diploma or general education diploma (GED).  Two years’ related experience or equivalent technical training/certification preferred; or a combination of related experience and technical training/certification. Physical Demands The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job:  Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear without any aids.  Capable of lifting or carrying and walk with a minimum of 30 kg alone without any support or aid and higher weights with support or aid as required.  Capable of moving the machines, filled containers, and other accessories alone or with support or aid as required.  Work different operational shifts from time to time as required.  Weekends / holidays and extended hours as required.  Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.  Operate trucks and other industrial vehicles to transfer the containers/production equipment.  Manufacturing operator/technician II are expected to operate any industrial machinery such as Forklifts, Hi-Lo, Reach Truck, Hand truck, Pallet Jack, Drum lifter etc. to lift, carry, push, pull or otherwise move objects. Work Environment The work environment characteristics described here are representative of those an individual encounter while performing the essential functions of this job:  Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.  Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.  Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.  Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face (Dust / Mist Respirator & Half-Face Air Purifying Respirator) and full-face negative pressure respirators  Individual may be required to wear hearing protection under certain conditions  Any employee required to use any type of Air Purifying Respirator must not have facial hair and must be cleanly shaven to assure a proper seal. Ingenus Pharmaceuticals LLC. is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, sex, color, religion, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status. Company DescriptionIngenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.Ingenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.

Job Description Job Title: Coating Operator II Department/Division: Manufacturing/Coating Reports to: Manager, Coating About LTS: LTS Lohmann Therapy Systems is a premier, global Contract Development and Manufacturing Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners’ market advantage. Every one of our 1,000 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes. We Care. We Create. We Deliver. Job Summary Lohman Therapy Systems North America is seeking a highly motivated and experienced Machine Operator with a strong focus on coating processes to join our growing team. In this role, you will play a crucial part in the successful production of high-quality products by operating and maintaining various coating equipment, ensuring optimal performance, and maintaining a safe and clean work environment. This is a full-time onsite position located in West Caldwell, NJ • Control and align multiple web paths during manufacturing with tension drive units, pressure rollers, and an edge guiding system., • Perform machine setups and correct machine functions., • Handle raw stock materials with a pallet jack., • Splice materials with a utility knife, tape gun, and splicing table., • Ensure proper disposal of hazardous waste, cleaning solutions, and adhesive compounds., • High school diploma or equivalent., • 4–5 years of machine operator experience, with at least 3 years of GMP manufacturing experience, preferably in the pharmaceutical field., • Experience with coating is preferred., • A strong mechanical aptitude and familiarity with equipment operation., • Strong math skills are a must., • Good reading, writing, and verbal skills., • Good computer skills to navigate systems and fill out necessary forms and documents., • Knowledge of laminating pressures for various types of films, fabrics, and foams., • Knowledge of Corona Treatment. LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Track and trend relevant quality metrics including environmental monitoring data., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • Computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description About Company: The Schreiner Group is a privately held, family-owned organization, operating with over 1,500 employees across three locations (Germany, China, US). As an internationally active, high-tech label manufacturer, we are mostly a strategic partner for our customers in the markets of healthcare & automotive industries. Our core business is innovative high-tech labels and functional parts. We increase the added value for our customers through suitable system solutions and services. The US operations are currently headquartered in Blauvelt, NY with plans to relocate to Chestnut Ridge, NY within the next two years. The brand-new location will offer the increased production, warehousing, and shipping capacity needed to support our continued growth in the market. In addition, the new facility will include a training center for our employees to enhance their skills, and to test new innovations. By focusing on our customers' needs, we are able to deliver excellent service in support of their goals. About the Role: The Quality Assurance Manager, reporting directly to the President of North American operations, will play a pivotal role in ensuring that all products meet the highest standards of quality and compliance within the wholesale trade industry. This position involves developing and implementing quality assurance policies and procedures that align the company's commitment to providing a safe work environment with regulatory requirements and industry best practices. The manager will lead a team of quality professionals, providing guidance and support to ensure effective testing and evaluation of products. Additionally, the role requires close collaboration with suppliers and manufacturing teams to address safety and product quality issues, and drive continuous improvement initiatives. Ultimately, the Quality Assurance Manager will be responsible for safeguarding the integrity of our products and maintaining customer trust through rigorous quality oversight. Responsibilities: • Coaches, mentors, and leads all employees in the Quality Assurance Manager’s areas of responsibility to achieve goals and objectives related to employee safety, quality control, quality assurance, customer demands, customer specifications, and environmental sustainability., • Works with the Engineering and Production Managers to help to lead continuous improvement activities and procedures to ensure efficient and compliant processes. Implements new procedures and policies in order to improve quality., • Assess training needs and ensure employees receive proper and timely training., • Oversee the training of all quality assurance personnel and other affected personnel as it relates to quality assurance policies and procedures., • Drafts and administers the Employee Performance Reviews and Disciplinary Actions for all quality assurance and quality control., • Creates and implements KPI’s for quality assurance and quality control., • Creates, implements, and ensures compliance with all company control documents as it relates to quality assurance and quality control (SOPs, Guidelines, Process Descriptions, and Forms and Checklists)., • Ensures all employees work according to the company’s cGMP and ISO standards., • Develops and communicates a monthly business review which includes performance and trending information (company meetings)., • Creates and maintains performance indicators, quality benchmarks, and measures performance on the quality assurance department (ie: deviations and non-conformations)., • Oversees all QA testing, performance indicators, and benchmarks for all projects., • Drives quality certifications and takes the lead on all audits (ie: ISO, Customer, Internal). Renews and maintains all documentation regarding certifications and other company licenses concerning quality control and assurance., • Develops and maintains quality improvement policies and procedures that meet legal and company requirement and standards., • Conducts quality audits of our vendors and suppliers to ensure conformity (internal and external)., • Develops all complaint investigation procedures, documents and makes recommendation for corrective actions, and ensures that proper follow up is taken. Shares all information with appropriate managers and personnel., • Investigates and provides support for recall and return of non-conforming raw material., • Tracks, reviews, and approves payroll for all quality assurance personnel. Manages overtime., • Oversees the daily functions of all quality assurance and quality control personnel ensuring all resources are being allocated effective and efficiently., • Ensures the proper flow of information to all quality assurance and quality control staff so everyone is on the same page., • Acts a liaison between different departments to provide status updates on projects or jobs., • Ensures that employees are adhering to proper company and Quality standards when carrying out their job duties., • Bachelor’s degree in science, Engineering or another related field., • 5 or more years of experience in quality engineering and management in a manufacturing environment., • Knowledge of cGMP/QSR, ISO and in a highly regulated field such as pharmaceutical, food, auto, etc., • Experience with Lean Manufacturing principles, 5S, Six Sigma, and other productivity and quality improvement methods., • Experience with OSHA and EHS regulations, practices, and reporting requirements that effect safety., • Experience with ERP/MRP systems, preferably SAP., • Intermediate to advanced level of computer knowledge in the Microsoft Office Suites/MS 365., • Reading, analyzing, and interpreting technical procedures, manuals and manufacturing documents including financial data as it relates to investments and personnel., • Ability to lift 30-50 pounds., • Standing or walking for long periods of time., • Work activity requires repetitive bending, reaching, walking, stooping, and crouching, lifting, and climbing. Job duties also require regular use of fingers and hand when working with material and equipment.

Job Description Company overview With an annual budget of $2.3 billion and more than 7,000 employees throughout the five boroughs, the New York City Department of Health and Mental Hygiene (NYC DOHMH) is one of the largest public health agencies in the world, serving 8 million New Yorkers from diverse ethnic and cultural backgrounds. We're tackling a broad range of public health issues with innovative policies and programs and getting exceptional results, but our work is never finished. The breadth of our innovative programs provides the widest range of choices for every member of our team. With grant funds from the Centers for Disease Control and Prevention (CDC), DOHMH is undertaking a new initiative that will meet critical infrastructure needs and make possible strategic investments that will have lasting effects on public health. Investments and improvements through this initiative will help modernize DOHMH’s foundational capabilities and data infrastructure, enabling it to partner in complex health and health care environments and, in turn, support better public health outcomes, including COVID-19. This initiative supports larger efforts to rebalance investments in public health and more equitably serve communities and populations. The selected candidate will be an employee of Public Health Solutions, a nonprofit organization which is the fiscal and administrative manager of the grant but will work be supervised by DOHMH. This is a grant-funded position ending in November 2027. DOHMH’s Office of Emergency Preparedness and Response (OEPR) was created to promote DOHMH’s and NYC’s ability to prevent, prepare for, respond to, and recover from health emergencies. The OEPR is responsible for coordinating agency-wide emergency preparedness planning, exercises and training, evaluation of incident response, and exercise performance as well as coordinating with community stakeholders, city, state, and federal partners on public health emergency planning and response. The OEPR also works with healthcare partners to optimize the provision of health services during a large-scale disaster. The Bureau of Emergency Field Operations (BEFO) is responsible for the planning, exercise, training, logistics, operations, and staffing of Citywide public health emergency plans and field operations including: Post Emergency Canvassing Operations (PECO), Community Reception Centers (CRC), quarantine operations, and antibiotic or vaccine Points of Dispensing (PODs). Job description DOHMH has an opening for a Vendor Manager. Reporting to the Senior Supply Chain Manager, this position oversees the Group responsible for coordinating and managing the services from various vendors, including a 3PL warehouse, which improve the readiness of NYC’s Public Health Emergency Stockpile, and the Citywide Health Emergency Field Operations Logistics Group, for response operations. Duties • Manage the Vendor management Group, including two coordinators, creating, and maintaining oversight of Group goals, objectives and milestones, and tracking through completion, • Oversee the execution, tracking and spend down of Bureau yearly fiscal contracts, procurement processes, and Bureau purchase order requests, • Manage the contractual relationship between DOHMH and the City’s 3PL emergency stockpile RSS warehouse, continuously enhancing readiness capabilities and ensuring all requirements are adhered to, including:, • Ensuring vendor purchases and maintains DOHMH indicated PPE (Living Stockpile) inventory in their nationwide distribution centers, that would be earmarked for NYC to use during an emergency, and update formulary as needed., • Overseeing the conduct of quality checks (inventory accuracy, product integrity) for PPE (Living Stockpile) and rotation to ensure stock is unexpired, and within acceptable shelf life., • Ensuring proper storage and maintenance of ventilators that would need to be brought to a “patient-ready” upon request, • Manage the maintenance, including rotation and shelf-life extension coordination, of a pharmaceutical cache to support first responders, healthcare workers and PODs, to support mass prophylaxis in response to an aerosolized anthrax release, • Oversee the adherence and maintenance of the cGMP compliance quality program, and liaise with ASPR/SNS to conduct yearly audits of the facility and validate product integrity, • Assist with the development, documentation, and testing of CHEFO ERG/ICS logistics roles, functions, responsibilities, and coordination processes; participate in drills and exercises, • It is expected that the Vendor Manager will be a key member of the incident command structure during emergency Qualifications: • Three or more years’ experience managing staff in an office setting supporting procurement, supply chain, or logistics operations through work related, but not limited to, any of the following areas: sourcing and procurement, fiscal process management and/or supply chain improvement, • Three or more years’ experience managing staff in an office setting supporting procurement, supply chain, or logistics operations through work related, but not limited to, any of the following areas: sourcing and procurement, fiscal process management and/or supply chain improvement., • Strong project/program management skills with experience developing written reports, policy/procedures and executive-level briefings, • Exceptional writing, communications, organizational and interpersonal skills, • The ideal candidate for this position must be a pro-active and self-motivated individual with the ability to work in teams and in a highly dynamic environment with multiple stakeholders and timelines. Additional Desired Qualities • Successful completion of the Incident Command System (ICS) and National Incident Management System (NIMS) courses (100, 200, 700, and 800), • Strong analytical skills and ability to manage and report complex information., • Desire to grow professionally, develop new skills and willingness to work outside of comfort zone., • Ability to prioritize and work in fast-paced environment with hard deadlines., • Generous Paid Time Off and Holidays., • An attractive and comprehensive benefits package including Medical, Dental and Vision., • Flexible Spending Accounts and Commuter Benefits., • Company Paid Life Insurance and Disability Coverage., • 403 (b) + employer matching and discretionary company contributions., • College Savings Plan. Additional Information: • This is a temporary grant-funded position ending in November 2027., • This individual must reside in the tri-state area (NY, NJ, CT) by their confirmed start date., • Preference may be given to individuals residing in New York City (5 boroughs) or surrounding New York State counties., • This individual will be expected to work non-business hours during emergencies. PHS is proud to be an equal opportunity employer and encourages applications from women, people of color, persons with disabilities, lesbian, gay, bisexual and transgender individuals, and veterans. Monday-Friday, 9am-5pm 35 hours per week

Job DescriptionDescription: RK Pharma Inc, a US based company with subsidiaries in India, is seeking a Microbiologist to join our growing team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. The position will perform all QC-Microbiology related testing activities such as Environmental, Water, and API and Drug Product release testing activities for RK Pharma. The position leads and supports the development, implementation, and maintenance of Quality Control (Microbiology) systems and activities for RK Pharma. This position is in Pearl River, New York, and is required to be onsite. Requirements:

Job DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description About Us: VuMedi is a leading healthcare technology company that specializes in providing innovative solutions for medical professionals to connect, learn, and collaborate. Our platform empowers healthcare providers with cutting-edge tools and resources to enhance patient care and drive positive outcomes. We are seeking a highly motivated and strategic Principal of Commercial Analytics to join our dynamic team. Job Overview: We are seeking a Principal of Commercial Analytics to join our fast-growing team. The ideal candidate will have 6+ years of hands-on analytics experience. They will be a vital part of our team, collaborating closely with customer sales, solutions, and product marketing teams. Their primary strength lies in translating business opportunities and challenges into analytics projects, carrying out the analyses, and delivering insights to create positive business impact. The ideal candidate will have strong leadership, strategic thinking, effective communication, and a results-oriented mindset. Key Responsibilities: • Pharma analytics: MUST have at least 5+ years of experience in analytics in Pharma space, • Data sources: Experience working with all/most of the below:, • Pharma sales, • Medical Prescriptions, • Medical claims, • Target lists, • Data from primary/secondary market research, • Campaign effectiveness analyses: MUST have experience running pharma promotional effectiveness analysis for Non-personal and personal channels using retrospective Test/Control analyses, A/B tests, Design of experiments, Marketing/Media mix modeling including ROI estimation. Experience in guiding pharma commercial resource allocation a bonus, • Statistics: Experience in inferential statistics such as hypothesis testing, creating confidence intervals, power and sample size calculations, t-tests, etc. Bonus: Experience in sampling techniques, and regression analysis, • Insights to action: 5+ of experience in translating complex and nuanced data analyses into business insights, and influencing decision making for internal or external marketing and sales leadership, • Strong Analytical Skills: Excellent analytical skills to effectively gather and interpret data, identify patterns, and draw actionable insights. Proficient in using analytical tools and techniques to solve complex problems and help make data-driven decisions. They should have experience using a wide variety of data to draw correlations, and actionable insights, • Strategic Thinking: The ability to think strategically is essential. They should be able to align analytics initiatives with the overall commercial goals and business objectives. This includes understanding business objectives, identifying key metrics, setting goals, and developing insights to drive commercial success., • Problem-solving and Critical Thinking: Should be adept at problem-solving and possess strong critical thinking skills. They should be able to analyze complex situations, break them down into manageable components, and propose innovative solutions to improve commercial success, including MVP (minimum viable product) solutions, • Technical expertise. Should have a deep understanding of data analysis methodologies, statistical techniques, and tools used for data manipulation, visualization, and modeling, • Communication and Influence: Should be able to communicate simple or complex data insights in a clear and concise manner to stakeholders at various levels within the organization. Your ability to influence decision-making through data-driven storytelling and compelling presentations is critical for driving the adoption of data-driven strategies., • Collaboration and Stakeholder Management: Needs to collaborate effectively with cross-functional teams and stakeholders. This includes partnering with CEO, sales and solutions teams, marketing, product managers, and executives to understand their needs, align analytics initiatives, and provide actionable recommendations., • Bachelor's degree in a relevant field (advanced degree preferred)., • Minimum of 5 years of experience in pharmaceutical analytics or a related field., • Strong quantitative and analytical skills, including expertise in statistical analysis and modeling., • Experience with pharmaceutical data sources, including IMS, Symphony Health, or similar datasets., • Excellent communication and presentation skills, with the ability to convey complex findings to non-technical stakeholders., • Detail-oriented with a commitment to data accuracy and quality., • Ability to work independently and collaborate effectively within a team., • VuMedi is a company that helps doctors stay educated, and improve their patients' outcomes. Our work is compelling and mission-driven, • Make a direct impact in the growth of the company, • Collaborative and innovative work environment that values creativity and professional growth, • Competitive compensation package and benefits

Job Description Description HistoWiz is the largest online histopathology company, based in New York City. Our mission is to help biomedical researchers find cures by accelerating histopathology and enabling global collaboration. Since inception in 2013, we have doubled our month-over-month sales, driven primarily by customer referrals. We are profitable, won numerous awards and are funded by prestigious investors, including Y-Combinator and Zhenfund. We are seasoned scientists with experience at leading academic institutions and have published high impact research in top journals of biomedicine. We have just completed our Series A and are now looking to scale our business significantly in the coming years. HistoWiz has over 3,000 paying customers globally from top academic institutions (e.g. MSKCC, Harvard, Stanford, HHMI) and pharmaceutical companies (e.g. CRISPR, Johnson & Johnson, Regeneron). We process tissue specimens and digitize all of the results, hosting our client’s data on a proprietary platform, PathologyMapTM . This platform not only enables industry-leading turnaround time for diagnosis, but also online viewing, sharing and search. No other platform like this exists, so we are truly building something new that can bridge scientists, doctors, and patients from all over the world to conquer life-threatening diseases collaboratively instead of individually. This online platform also contains the world’s largest collection of pathology data and the first network of top pathologists. We are looking for highly motivated IHC Lab Assistant to join our fast-growing team. Under the general direction and supervision of the Director of Laboratory Operations, the IHC Lab Assistant will effectively apply a working knowledge and skill of designated IHC Lab Assistant-related duties and tasks, in support of the Department as a whole, to complete the daily assigned workload. Requirements Must possess a thorough working knowledge of the IHC staining procedures, Histochemical staining procedure and routine Histology procedures sufficient to accomplish the following: • Organizing and maintaining the laboratory to ensure a clean, safe, and efficient working environment, • Shipping and receiving client projects and samples, including preparing and labeling materials for transport, • Maintaining inventory and supplies, including ordering and restocking as needed, • Performing slide and cassette printing, slide cleaning, and scanning according to established protocols, • High school diploma along with some lab experience, • Tech-savvy, fast learner. We use a proprietary, digital LIMS system, • Strong verbal and written communication skills Oh72OTrpBt

Job DescriptionCompany Description Derex Technologies Inc specializes in providing IT consulting, staffing solutions and software services. Globally headquartered in Harrison New Jersey since 1996 Derex delivers the highest quality technology professionals and an array of customized IT talent solutions designed to improve productivity and drive results to global clients throughout North America. With over two decades of unparalleled experience, Derex provides supports to its clientele, across such industries as Systems Integration, Banking and Finance, Telecommunications, Pharmaceutical and Life Sciences, Energy, Healthcare, Technology, Transportation, and local and federal Government agencies. Job Description Position: Software Engineer – DevOps Location: Parsippany, NJ (On-Site) Full Time Job Overview Seeking a highly motivated and experienced DevOps Engineer to join our dynamic technology team. In this role, you will be instrumental in building, automating, and maintaining our robust and scalable infrastructure, ensuring our applications and services' smooth and efficient delivery. You will collaborate closely with development, operations, and security teams to streamline our deployment processes, enhance system reliability, and drive continuous improvement. Responsibilities: • Utilize strong Git knowledge for version control, branching strategies, and collaborative development workflows., • Proficiently manage code merges, resolve conflicts, and ensure code quality within the Git repository., • Develop and maintain automation scripts and tools for infrastructure provisioning, configuration management, and application deployments., • Implement and manage continuous integration and continuous delivery (CI/CD) pipelines using industry-standard tools., • Design, implement, and manage our Windows-based infrastructure, including Windows Servers and Internet Information Services (IIS)., • Monitor system performance, identify bottlenecks, and implement solutions to optimize efficiency and reliability., • Troubleshoot and resolve application deployment issues in a timely and effective manner., • Collaborate with development teams to understand application requirements and ensure smooth and efficient deployments., • Implement and maintain security best practices within the infrastructure and deployment processes., • Participate in on-call rotation to support production environments., • Document infrastructure configurations, deployment procedures, and troubleshooting steps., • Stay up to date with the latest DevOps trends, tools, and best practices. Skills and Qualifications • Bachelor’s degree in computer science, Engineering, or a related field., • 5-7 years of experience in DevOps,, • Deep understanding and hands-on experience with Internet Information Services (IIS) configuration, management, and troubleshooting., • Strong scripting skills in PowerShell., • Experience with CI/CD tools such as Azure DevOps, Jenkins, GitLab CI, and similar., • Experience with configuration management tools such as Ansible, Chef, or Puppet (PowerShell DSC preferred)., • Familiarity with cloud platforms such as Azure or AWS., • Experience with monitoring and logging tools (e.g., Dynatrace, Prometheus, Grafana, ELK stack, Azure Monitor)., • Excellent problem-solving and analytical skills., • Strong communication and collaboration skills., • Demonstrated strong knowledge of Git and Git workflows., • Proven ability to effectively manage code mergers and resolve conflicts. Qualifications • Experience as a .NET developer or strong understanding of the .NET development lifecycle and deployment processes., • Experience with containerization technologies such as Docker and orchestration tools like Kubernetes., • Knowledge of security best practices in cloud and on-premises environments., • Bachelor’s or master’s degree in a computer-related field. Key Competencies Communicates effectively– Attentively listens to others, provides timely and helpful information and is effective in a range of professional settings. Gives and receives feedback in a productive, professional manner. Demonstrates excellent oral and written communication skills. Manages Ambiguity -Operating effectively, even when things are not certain, or the way forward is not clear. Is flexible in approach and is able to adapt their approach to meet changing business needs. Manages complexity -Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems. Has strong organizational skills and is able to manage multiple activities at once. Has high attention to detail. Ensures Accountability -Follows through on commitments and makes sure others do the same. Able to work independently as part of a small team. Regards, Manoj Derex Technologies INC Contact : 973-834-5005 Ext 206 Additional Information All your information will be kept confidential according to EEO guidelines.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: • Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols., • Create and execute product/process enhancement, and new product/process development plans., • Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results,, • Author protocols and reports including engineering studies and design verification/validation activities., • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis., • Participate in voice-of-customer (VOC) labs and other user needs assessments., • Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes., • Support process and product transfers to manufacturing or CDMOs., • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines., • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions., • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline., • Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)., • Proficiency as an adept experimentalist with hands-on experience in the process development of polymeric materials and their characterization in an R&D or manufacturing environment., • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks., • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills., • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements., • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required., • Requires excellent written and verbal communication and presentation skills., • Legal authorization to work in the United States is required., • Physical Requirements include:, • Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training., • Wear Appropriate Personal Protective Equipment (PPE):, • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment., • Ability to speak, listen, and understand verbal and written communication., • Possesses hand-eye coordination and manual dexterity for delicate manipulations., • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects., • Visual acuity is required for performing close and distant activities. Preferred Qualifications • An advanced technical degree (MS or PhD)., • ·Lab experience in an industry setting within cGMP-regulated environments., • Prior experience developing processes and scaling these up into manufacturing or CDMO, • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment, • Six Sigma green belt or black belt certification preferred., • Experience implementing process and quality improvements in a manufacturing environment, • Work experience with the medical device or pharmaceutical industries, • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200., • Working knowledge of FDA requirements as per 21 CFR 820. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job Description Join The WorkPlace Group’s Pharmaceutical Talent Pool! Are you a passionate professional in the pharmaceutical industry looking for your next career opportunity? The WorkPlace Group is excited to invite you to join our exclusive candidate talent pool! Why Join Us? • Exclusive Opportunities: As a Leading Recruitment Process Outsourcing (RPO) and Executive Search provider, we know about job openings before they become public. We also have direct access to the Company’s Hiring Managers and serve as their exclusive and in-house recruiter., • Priority Consideration: When a job needs to be filled, our recruiting teams first look for candidates in our database and candidate network. By sharing and uploading your resume, you can gain access to a wide range of job openings in leading pharmaceutical companies., • Pharmaceutical Professionals: Whether you’re in research, development, manufacturing, quality control, regulatory affairs, or sales, we want to hear from you!, • Common Job Titles: We frequently fill positions such as Research Scientist, Clinical Research Associate, Quality Assurance Specialist, Regulatory Affairs Manager, Pharmaceutical Sales Representative, and more. Visit our website to see a complete list of job titles., • Experienced and Entry-Level Candidates: We welcome candidates at all stages of their careers., • Upload Your Resume, • Stay Connected and follow us on LinkedIn, Instagram and X For more information, visit our website at

Job DescriptionCompany Description Eurofins Scientific is a network of independent companies providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. With more than 20 U.S. locations, Eurofins Built Environment Testing offers Industrial Hygiene (IH) and Indoor Air Quality (IAQ) services to protect health in built environments. Clients include consultants, industry, real estate, healthcare, government, and homeowners. Services cover a wide range of tests, including asbestos (PLM/TEM), mold, bacteria, VOCs, allergens, Legionella, radon, lead, silica, and more. Job Description Eurofins Built Environment Testing is looking for an experienced TEM Asbestos Analyst in our Seattle, WA location. Relocation assistance may be available for the right candidate. The Analyst performs analysis of bulk and air for asbestos mineral fibers using TEM -Transmission Electron Microscopy. Analyst prepares and analyzes environmental samples according to scientific methodology in compliance with company Quality Assurance programs and SOP’s, and must be knowledgeable of both job-specific routine and complex analyses. The analyst validates and reviews data for accuracy, and uploads laboratory data into the LIMS that ultimately generates required reports to clients. Schedules sample workload according to due dates and sample hold times, and must be knowledgeable of the job-specific laboratory testing equipment, requiring the exercise of discretion and judgment in its operation. Responsibilities: • Prepare and analyze environmental samples for asbestos using TEM microscopy., • Adherence to EPA, NVLAP, ELAP, OSHA, and NIOSH standards for asbestos identification, • Accurately enters and reports analytical data using the LIMS, • Performs independent data reviews for other analysts’ work, • Performs analysis of reference materials, proficiency samples and other quality control samples as needed, • Maintains client service and provides technical support as needed, • Assists the QA manager in development, implementation and data collection of QA processes for the different analytical tests, • Performs confirmation of lab results as needed by client services personnel, • Performs and completes all analytical testing QA related tasks as needed, • Assists in pursuing, receiving and maintaining necessary laboratory accreditations, • Maintains and updates all necessary Training and QA documents onsite as necessary, • Co-ordinates and manages projects according to their rush status and due time for timely delivery, • Assists co-workers on analytical questions, as necessary, • Participates in Lean initiatives and projects when called upon, • Manages and maintains the inventory of re-sale supply items and laboratory consumables and takes necessary steps to re-order supplies as needed, • Manages and disposes analyzed samples as needed, • Trains new asbestos testing Analysts as needed, • Recommends and coordinates sample transfer as necessary, • Establishes and maintains laboratory reference samples, • Performs root cause analysis and determines and implements corrective actions for errors and issues as necessary, • Maintains all equipment properly and co-ordinates servicing of all equipment used in the laboratory, as needed, • Routinely communicates available capacity to Regional Manager, • Supports other departments within the lab (mycology, asbestos, bacteriology, and other) when appropriate and as needed, • Other responsibilities as deemed necessary by the Supervisor/ManagerQualifications Basic Minimum Qualifications: • 1+ years of experience performing asbestos microscopy, • Must have an undergraduate degree in Geology, Biology or related science, or TEM Asbestos training course, • Experience utilizing a Transmission Electron Microscope preferred, • Must be willing to relocate to Seattle, WA, • Authorization to work in the United States indefinitely without restriction or sponsorship., • Professional working proficiency in English is a requirement, including the ability to read, write and speak in English Additional Information Compensation range: $23 - $27 per hour depending on qualifications and experience. • Position is Full-time Monday - Friday , 8AM - 5PM shift with overtime or weekend work as needed. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options. We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: Company description: Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR 6.95 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional weekends, nights, and/or holidays as required/necessary.May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.Must be able to handle the standard moderate noise of the manufacturing facility.Must be able to work in open floor plan environment and may work in close proximity to others.Wheel-o-Vator available for use.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements, • Travel may be requiredREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAssociate Director, Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Operations is responsible for efficient utilization of Operations resources to meet customer demand. This role will be responsible for maintaining and overseeing the site Operations scheduling and training capacities for a time period looking ahead to the next 3-6 months. The Associate Director, Manufacturing Operations will understand upcoming needs and constraints and help drive strategy accordingly. This includes the management of all Operations scheduling, training and compliance resources. The Associate Director, Manufacturing Operations is also responsible for assessing the needs of the company to contribute to the big picture by ensuring daily operations run smoothly and as efficiently as possible. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meeting client process demands through planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contracts, • Looking out 3-6 months to ensure capacity and availability of resources (room/equipment/staff) to perform clinical manufacture for processing needs, • Manages all training and compliance activities in the Operations organization, • Responsible for creating, enforcing and measuring Operator training schedules in order to ensure that all production schedules can be carried out, • Creates and maintains a process to ensure that personnel schedules are being accurately and fairly assigned to all Associates, • Supporting and driving special long-term projects and identified and assigned by the PPU Head, • Responsible for creating maintaining and communicating all Operations based KPI’s, • Ensuring department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices, • Approving job specific curriculum for the training and professional development of department staff, • Responsible for streamlining the batch record review process, • Responsible to understand the profit and loss for the PPU’s as well as all related documentation, and how these items impact Operations, • Driving continuous improvement, • Liaison with support groups for short- and medium-term needs – Supply Chain, Training, Quality Systems, Quality Assurance, Quality Control, and others, • Set team expectations and goals and assists in delivering the business direction for the PPU, • Aligning departmental goals, processes and resource allocation with the organizational strategy, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Direct reports: Associate Manager Training, Associate Manager, Compliance, Scheduling Associate, Quality Engineer Associates. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. REQUIREMENTS, • Bachelor's degree (i.e. Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-10 years of cGMP environment, aseptic processing, mammalian cell culture, monoclonal antibody, cell processing, cryopreservation or similar experience., • 5-10 years of leadership experience or equivalent combination of experience., • Deep Understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (able to work with Microsoft Office and corporate scheduling system), • Competencies/Candidate Profile, • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Flexible and able to adapt to company growth and evolving responsibilities, • Accountability, integrity, and strong dedication to regulatory compliance, • Strong business and personnel management acumen, • Strong emotional intelligence, • Ability to think strategically and tactically (detail-oriented), • Strong analytical and problem-solving skills, • Strong written and verbal communication skills, • Drive to create and maintain order in a fluid, technically complex environment, • Continuous improvement mindset, • Ability to multi-task is essential, • Must have the ability to work in a team-oriented environment and with clients, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.Duties, responsibilities, and activities may change at any time with or without notice

Job DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. Leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Manage CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field or equivalent experience., • 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience., • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA, • Must have technical experience writing and assessing deviations, investigations, and Out of Specifications, • Must be able to analyze data/information and to assess and resolve complex problems, • Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing, • Knowledge of operational processes and controls in non-sterile and sterile operations, • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Training; GMP Training, Quality Systems Training (Deviation/CAPA), Safety Training, Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAbout CookUnity Food has lost its soul to modern convenience. And with it, has lost the power to nourish, inspire, and connect us. So in 2018, CookUnity was founded as the first-of-its-kind platform that connects the world with the source of truly great food: chefs. Today, CookUnity delivers 50 million meals a year from the industry's best chefs to homes all over the country. Fresh. Ready-to-eat. And crafted with the passion that nourishes body and soul. Unwilling to stop there, CookUnity is expanding beyond delivery to become an ever-innovating marketplace focused on our singular mission: empower Chefs to nourish the world. If that mission has you hungry in more ways than one, you've found the right job posting. The role: We're looking for a Sr Manager - Fulfillment Process Engineering to join our Fulfillment & Logistics team. This role will play a vital part in optimizing end-to-end cold chain processes, from production handoff to last-mile delivery, improving efficiency, quality, and scalability across our multi-site fulfillment network. Responsibilities: • Evaluate and enhance cold chain fulfillment workflows to reduce quality defects including missing meals, incorrect meal placement, broken seals, and missing packages., • Develop SOPs and standard work for operation of sealing machines, sleeving stations, and other critical fulfillment equipment to improve consistency and reduce human error., • Partner with operations leaders to roll out process improvements and programs that enhance the handoff from fulfillment to logistics — including packaging validation, temperature control checkpoints, and loadout readiness., • Create training documentation and visual work instructions to standardize best practices across fulfillment centers., • Lead cross-functional root cause analysis initiatives for recurring quality or efficiency issues; implement countermeasures and follow-through audits., • Support layout optimization of fulfillment lines and cold pack areas to improve flow, reduce dwell time, and increase packaging throughput., • Establish performance dashboards and KPIs to track packaging accuracy, seal integrity, and cold chain compliance across the network., • Partner with design and maintenance teams to influence equipment upgrades and new site layouts based on observed performance gaps., • Lead Kaizen events or structured continuous improvement cycles across fulfillment centers focused on operational and quality gains., • Train and mentor site leaders and team members on process control, lean methodologies, and six sigma tools.Qualifications:, • Bachelor's degree in Engineering (Industrial, Mechanical, Supply Chain) or related STEM field., • 5+ years of hands-on experience in process engineering within cold chain, logistics, food, pharmaceutical, or fulfillment industries., • Proven track record leading large-scale process improvement initiatives in a distributed operations network., • Ability to thrive in high-velocity environments, balancing strategy with hands-on problem solving., • Willingness to travel 25–50% across CookUnity's fulfillment sites.Preferred requirements:, • Master's degree in Engineering, Supply Chain, or Business., • Lean Six Sigma certification (Green Belt or higher)., • Experience designing fulfillment or production layouts involving temperature-sensitive products and packaging equipment., • Proficient in data analysis tools, simulation software, and process documentation tools (e.g., Tableau, Minitab, AutoCAD, Lucidchart)., • Experience collaborating across functions (Design, Ops, Quality, Logistics) to implement enterprise-wide process changes. We hope this provides valuable insight into our culture and product vision. If this excites you, we'd love to connect! Benefits 🩺 Health Insurance coverage 🌅 401k Plan 📈 We grow, you grow: Stock Options Plan granted on Day 1 🌟 Eligible for a bi-annual performance bonus ⛱ Unlimited PTO 🗓️ 5- year Sabbatical: After 5 years with CookUnity, you get a 4-week paid sabbatical 🐣 Paid Family leave 🕯 Compassionate Leave: 3-5 days each time the need arises 🥘 A generous amount of CookUnity credits to enjoy our amazing meals, added to your account, monthly 🧘🏽️‍♀️ Wellness perks: access to a nutritional coach and fitness subsidies to build a healthy lifestyle 👩🏾️‍🏫 Personalized Spanish coach 🚀 Awesome opportunity to join a company that is looking to change how we eat and how chefs work! Compensation All final pay rates will be determined by candidates experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.Pay Range for this position$120,000—$130,000 USD If you're interested in this role, please submit your application and if we think you might be a fit, we'll get in touch with you. Thank you for your time! CookUnity is an Equal Opportunity Employer. We are dedicated to creating a community of inclusion and an environment free from discrimination or harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, citizenship status, protected veteran status, genetic information, or physical or mental disability.

Job DescriptionQuality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. • Develop and maintain training program within Quality Control which includes, onboarding and continuous training, • Manage deviations, CAPAs, change controls and document review to ensure compliance, • Ensure OOS investigations are completed adequately., • Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories, • Identify resources needed for training and compliance and build team accordingly, • Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements., • Monitor effectiveness of CAPAs, change control activities, and audit observation closure., • Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators, • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory experience in a cGMP environment a must, • 3-5 years’ experience in the pharmaceutical, biologics ore related industry, • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position, • Sound understanding of cGMPs, • Experience in laboratory training and compliance, • External laboratory management experience, • Strong knowledge of testing methodologies, philosophies, method validation and method transfers., • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Experience with laboratory training programs, • Knowledge of GMP requirements, • Excellent organizational and leadership skills, • Outstanding analytical problem-solving abilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are excited to accept applications for future opportunities. Join our talent pool for future openings by applying now. This is a W2-Temp 6-month role with potential FTE extension.We are seeking a highly skilled and detail-oriented Quality Assurance Engineer to join our team in the life science sector. The ideal candidate will have a strong background in quality assurance processes, with specialized experience in auditing, ensuring compliance with regulatory standards, and maintaining the highest quality standards in pharmaceutical production. This individual will play a crucial role in the review and assessment of manufacturing practices, quality control systems, and regulatory compliance within a highly regulated environment. • Develop, implement, and maintain quality assurance processes and procedures in alignment with industry standards and regulations., • Ensure all manufacturing processes comply with relevant regulations, including but not limited to FDA, EMA, ICH, and GMP guidelines., • Review batch records, validation documentation, and quality control data to ensure compliance and product quality., • Conduct internal and external audits to assess compliance with Good Manufacturing Practices (GMP), FDA regulations, and other relevant standards., • Collaborate with cross-functional teams to ensure effective implementation of audit findings and continuous improvement initiatives., • Prepare detailed audit reports, CAPA (Corrective and Preventive Actions) reports, and other documentation as required., • Maintain thorough and accurate records of quality assurance activities, audits, and regulatory communications., • Participate in the preparation and review of SOPs, work instructions, and other quality-related documents., • Lead or participate in continuous improvement initiatives, focusing on quality and operational efficiency. Requirements • Bachelor's degree in engineering or related technical field., • Minimum of 5+ years of experience in quality assurance within the life science industry., • Proven experience in conducting GMP audits, both internal and external, in a pharmaceutical or life sciences environment., • Experience with regulatory bodies such as the FDA, EMA, and other international regulatory agencies., • Familiarity with Quality Management Systems (QMS), CAPA, deviation management, and risk management., • Strong understanding of GMP regulations, FDA guidelines, and other applicable industry standards., • Excellent analytical and problem-solving skills., • Exceptional attention to detail and ability to identify potential areas of risk and non-compliance., • Strong verbal and written communication skills, with the ability to prepare clear and concise reports., • Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RW1 BenefitsW2 Temp positions include our medical and sick time benefits. Adhering to the requirements of New Jersey's law on salary transparency, the salary bracket for this role is set between $100,000 - $115,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

Job DescriptionDescription: RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing Quality Assurance team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. This position will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance. Requirements: If this sounds interesting to you, it’s probably because up to this point you have: • A science degree, specifically in Microbiology., • Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency., • Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology., • Thrived in an environment where growth and change are rapid., • Strong Quality Control background preferred. The main responsibilities for this position are: • Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies., • Revise quality and compliance standard operating procedures as required., • Review Quality Control method validation and method transfer protocols/reports., • Assist with Internal Audits., • Collaborate in management of deviations/CAPAs/change controls., • Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance., • Assist in the preparation and review of the Annual Product Review. If this sounds like something that is of interest to you, please don’t hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.

Job DescriptionDescription: Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and cryopreserved allogeneic cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. For more information about Celularity and its cutting-edge regenerative medicine solutions, please visit . Summary: Celularity is seeking a Sr. Facilities Engineer to join our facilities operations team in Florham Park, NJ. The role is responsible for performing highly diversified duties required to operate and maintain facilities mechanical systems including boilers, HVAC systems (air handlers/chillers/humidifiers/AC units/exhaust systems/associated controls), compressed air, bulk gas systems, generators, electrical, plumbing, etc. This position includes supervising staff level building engineers/mechanics as well as critical oversight of contractors. The position also provides first response technical support and planning to maximize equipment uptime, evaluating equipment failures while analyzing performance and being involved in design improvements to increase the reliability of our assets. This position will also include conducting Preventive Maintenance (PMs) and repair of various facilities systems as well as supervising and overseeing contractors to ensure proper performance and quality workmanship that meets our scheduling milestones and budget limits. Requirements: • Lead and develop staff building mechanics and engineers in the preventive and corrective maintenance of all facility systems to sustain and improve overall facility uptime and safety objectives., • Oversee external service providers for equipment maintenance, HVAC, etc., • Troubleshoot, repair, maintain, and improve mechanical equipment and components., • Maintain boilers, compressors, vacuum pumps, HVAC systems, humidifiers, etc., • Utilize our asset management software to document proper maintenance of equipment, identify equipment problems, obtain parts, document findings, track personal labor hours and material on jobs, capture repair history, etc., • Support and supervise after-hours response to emergencies and take appropriate action to identify problems and take corrective actions., • Review, execute and approve work orders, logs, forms and related documentation on a daily basis to ensure they are complete, current, and reflect the tasks as performed, and are appropriated filed in., • Recommend and assist in executing facility expansions and improvement projects through effective project oversight and cost control., • Promote working safely, conduct inspections, resolve conflicts to protect employees’ health and wellbeing., • Adhere to budget in areas of facility expenditures, • Provide engineering support, technical expertise and problem solving to all departments., • Provide technical expertise and recommendations for facility improvements., • Gather and analyze data, blueprints, and reports., • Analyze condition, troubleshoot failures, perform facility and infrastructure repairs., • Lead, manage and develop facilities mechanics and building engineers., • Utilize Siemens Building and Environmental Management to investigate alarms and resolve any related systems issues to maintain proper environmental controls in regulated pharmaceutical cleanroom environments., • Comply with relevant regulations, building codes and EHS standards., • Collaborate and support other departments within Celularity for special projects as necessary., • Weekend work, • Working overtime, • This position requires frequent walking, climbing, bending, kneeling, lifting, stooping, and working/extending overhead, including:, • Frequent physical demands including lifting up to 50 lbs., • Using ladders up to 20 ft and working from heights., • Climbing a ladder and work from lift, • Must pass background, drug/alcohol screening.

Job DescriptionCompany Description The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you’re looking for a rewarding career, a place to call home, apply with us today! Job Description POSITION SUMMARY: We have an exciting opportunity to support our client in analytical testing and implementation of novel analytical methodologies for our clients CAR-T cell therapy products. These Scientists will work with a talented and experienced client team in Research and Development and will be important points of contact for the coordination and execution of molecular, potency and characterization assays, qualification studies, and method transfer activities within area of expertise. This team will interface regularly and build relationships with other functions at the client site such as Process Development, Quality Control and Manufacturing Sciences & Technology to collaboratively drive projects to meet the established timelines while maintaining the highest quality and data integrity standards. POSITION RESPONSIBILITIES: • Perform analytical testing including flow cytometry, cell count, cell viability, qPCR/dPCR, ELISA, potency, etc. following appropriate SOPs and procedures. In addition, review and approve data by other team members, • Record and maintain meticulous records in electronic laboratory notebook in compliance with Quality standards, • Identify opportunities for method improvement, • Execute qualification/optimization of analytical methods, • Drive project timelines and deliverables while meeting internal quality and data integrity requirements, • Communicate effectively and present complex data within the department and cross-functionally, • Author and review method related technical documents to ensure completeness, accuracy, consistency and clarity, • Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiencyQualifications BASIC MINIMUM QUALIFICATIONS: • BA/BS or MS in biology, chemistry, biochemistry, microbiology or other related science, plus 1+ year of prior experience in industry or academia., • Understanding of the basic scientific principles underpinning the analytical methods such as flow cytometry, PCR, ELISA, cell-based assays, • Expertise with aseptic technique, • Ability to communicate clearly with internal or cross-functional teams, • Detail-oriented with expertise in problem solving & demonstrated ability to work in a team environment, • Established ability to work in a regulated environment, • Good presentation skills and scientific/technical writing skills, • Understanding of the concepts of cGxP, • Experience with mammalian cell culture, Human T-cell culture, • Experience writing laboratory SOPs and technical instructions, • 1-3 years of experience in pharmaceutical, biologics industry Additional Information Position is Full Time, Monday – Friday First Shift. Candidates currently living within a commutable distance of East Hanover, NJ are encouraged to apply. Excellent full-time benefits include: • Comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match, • Paid vacation and holiday, • Yearly goal-based bonus & eligibility for merit-based increases

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The Preclinical Principal Scientist will serve as a key scientific contributor, subject matter expert (SME) and Project Manager in the execution of Cresilon’s Preclinical Research Operations, including but not limited to in-vivo study design (Safety and Efficacy/Functionality evaluations), Preclinical Research Management, Vendor Management, and Preclinical Regulatory Strategy. This will include the development and execution of strategies for preclinical evidence necessary to competitively position a project’s product for domestic and international regulatory and clinical acceptance. This position as a hybrid role, with work off-site at CRO in NY/NJ area, work from home and on-site at Brooklyn NY. Job Responsibilities: The Preclinical Research Scientist will: • Lead, staff, and manage Cresilon’s Preclinical Research activities., • Provide preclinical scientific input and leadership on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life cycle., • Plan, direct, coordinate and execute activities related to the design, initiation and follow-up of studies to support approval of Class I-III medical devices., • Develop, write, and/or review study protocols and reports. Act as technical mentor for the development of study experimental designs, protocols, and reports of junior associates., • Administrate and manage Cresilon preclinical regulatory strategy and communication., • Work with Contract Research Organizations (CROs) to execute both Biocompatibility / Safety and Efficacy/Functionality research, including negotiating, drafting, and managing research contracts and agreements with pre-clinical trial sites., • Ensure that company operates within the scope of regulatory compliance including Quality System Regulations (ISO 13485), health and safety, environmental protection regulations, and the core values of Cresilon., • Be a Subject Matter Expert (SME) for preclinical research department growth strategy. Actively interact with the internal and external scientific community to maintain state of the art knowledge., • Oversee the development of and modifications to preclinical models to address project needs., • Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines., • Surveys the literature to identify and compare competitive product performance and safety risks., • Maintain current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, FDA, etc) and compliance requirements (GLP, USDA, AAALAC, departmental SOP's, company policies, etc), • Work cross functionally with Regulatory and Quality to assess project risks, product safety and efficacy on NPD projects, including ensuring external facilities meet Cresilon standards for animal use and generating contracts and CRO audits, if necessary., • Manage budgetary requirements for all research projects to support efficacy and safety programs., • Lead the effort to publish surgical research in peer-reviewed journals., • Regularly interface with management to ensure research operations reflect overall corporate vision/strategy., • DVM, PhD or MD in a relevant discipline is preferred. A Bachelor's in a technical or scientific field is required., • Minimum 6+ years’ experience in preclinical medical device research is required, preference given to veterinary surgical or human surgical experience., • 4+ years of people management experience preferred., • Extensive knowledge of surgery, anatomy, toxicology, and pathology is required., • Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices is highly preferred., • Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects is highly preferred., • Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations., • Experience with surgical publication submission strategy is strongly preferred., • Strong communication skills (both written and verbal) is required with the ability to extract key facts from complex information and present concise summaries to management., • Demonstrated experience with large animal in vivo surgical research and CRO vendor management is required., • Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred., • Excellent problem solving, conflict resolution, and analytical skills is required., • Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment is required., • Prior experience and ability to work well with external CROs and collaborators with professionalism and discretion is required., • Requires strong leadership and organizational skills including attention to detail and multi-tasking skills., • Able to understand and execute to project details but keep overall “big picture” view of projects, priorities, and strategies is required., • Medical Device product development experience, including knowledge of medical device regulations, regulatory/notified body requirements is preferred., • Good Laboratory Practices (GLP) experience preferred and working knowledge of Good Manufacturing Practices (GMP), • Experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations is preferred., • Hands-on research experience with hemostatic devices and/or coagulation chemistry, strongly preferred., • Legal authorization to work in the United States., • This position is located in Brooklyn, NY and may require up to 30% travel (to monitor and execute out-sourced studies) Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $130,000 - $210,000, depending upon job level and qualifications., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job DescriptionCompany Description The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you’re looking for a rewarding career, a place to call home, apply with us today! Job Description POSITION SUMMARY: We have an exciting opportunity for a Senior Scientist Group Leader to support and lead a team supporting our client in analytical testing and implementation of novel analytical methodologies for our client's CAR-T cell therapy products. This team will work with a talented and experienced client team in Research and Development and will be important points of contact for the coordination and execution of molecular, potency and characterization assays, qualification studies, and method transfer activities within area of expertise. This team will interface regularly and build relationships with other functions at the client site such as Process Development, Quality Control and Manufacturing Sciences & Technology to collaboratively drive projects to meet the established timelines while maintaining the highest quality and data integrity standards. POSITION RESPONSIBILITIES: • Perform analytical testing including flow cytometry, cell count, cell viability, qPCR/dPCR, ELISA, potency, etc. following appropriate SOPs and procedures. In addition, review and approve data by other team members, • Supervise PSS team, • Record and maintain meticulous records in electronic laboratory notebook in compliance with Quality standards, • Identify opportunities for method improvement, • Execute qualification/optimization of analytical methods, • Drive project timelines and deliverables while meeting internal quality and data integrity requirements, • Communicate effectively and present complex data within the department and cross-functionally, • Author and review method related technical documents to ensure completeness, accuracy, consistency and clarity, • Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiencyQualifications BASIC MINIMUM QUALIFICATIONS: • BS in biology, chemistry, biochemistry, microbiology or other related science with 5+ years industry experience or MS and 3+ years of industry experience, • Leadership skills, • Understanding of the basic scientific principles underpinning the analytical methods such as flow cytometry, PCR, ELISA, cell-based assays, • Expertise with aseptic technique, • Ability to communicate clearly with internal or cross-functional teams, • Detail-oriented with expertise in problem solving & demonstrated ability to work in a team environment, • Established ability to work in a regulated environment, • Good presentation skills and scientific/technical writing skills, • Understanding of the concepts of cGxP, • Experience with mammalian cell culture, Human T-cell culture, • Experience writing laboratory SOPs and technical instructions, • 3-5 years of experience in pharmaceutical, biologics industry Additional Information Position is Full Time, Monday – Friday First Shift. Candidates currently living within a commutable distance of East Hanover, NJ are encouraged to apply. Excellent full-time benefits include: • Comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match, • Paid vacation and holiday, • Yearly goal-based bonus & eligibility for merit-based increases

Job DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to conduct investigation and CAPA processes., • Conduct investigation and identify true root cause using appropriate tools., • Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates., • Reviews and approves investigations and CAPAs when required;, • Collaborate with cross functional department to develop and track CAPA plans., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Other duties as assigned.REQUIREMENTS, • B.S in biological sciences or other relevant field of study., • Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Competencies/Candidate Profile, • Relevant computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to work in a team-oriented environment., • Must be able to work occasional weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-o-Vator available for use. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Control Analytical ScientistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a Senior Member of the team the QC Analytical Scientist will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle. • Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients., • Support routine GMP testing as assigned. Mentor and train team members, • Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements., • Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports., • Create validation project plan i.e., timelines and resources and provides status updates to management. Utilize statistical tools for evaluation of method validation and trending data., • Identify, evaluate, and implement continuous business process improvements., • Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS)., • Provide support during laboratory investigations., • Train QC personnel during method transfer and validation. Provide support during equipment qualification., • Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices., • Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures., • Indirectly may supervise cross functional teams including product development, QA, PMP, and Manufacturing.REQUIREMENT, • B.S Analytical Chemistry or other scientific field or MS/Ph.D. in Analytical Chemistry or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products., • 8-10 years of experience in the areas of method development, validation, and transfer., • Direct GMP Experience., • Proficiency in project management skills and tools., • Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc., • Extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs., • Strong Quality orientation with attention to detail required. Analytical and problem-solving skills required., • Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution., • Excellent presentation skills. Ability to communicate to upper management, across departments and within the immediate QC team., • Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction., • Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external., • Must be familiar with GMP lab environment and Aseptic techniques.Working EnvironmentMust have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays, or overtime and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facilityMay work with hazardous materials and chemicals Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall Responsibilities For Quality Operations And Initiatives, Including • Quality Assurance management:, • Documentation control (master batch record, specification and method), • Batch record review and product disposition, • Investigations, complaints, deviations, CAPAs, APRs, • Production and Pharmaceutical Development support, • APRs, GMP training and SOP review, • Validation / qualification documentation review and approval, • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site, • Develop, maintain, and enhance training programs and systems, • Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives., • Must be able to move about the facility, • Experience with FDA Audit, • Extensive knowledge of US and EU current Good Manufacturing Practices, • Experience with a CDMO would be preferable, • In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for: i). Quality Compliance management: ii). All audits, internal, external - regulatory, client and vendor iii). Vendor management program iv). QA Agreements with clients & contractors v). License renewals Company DescriptionWe are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..

Job DescriptionQuality Assurance Manager (Compliance)Allendale, NJ The Manager, Quality Assurance manages the PPU support unit services of the QA Department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. • The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes., • Start-up Compliance arm of the Quality Assurance Department., • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality AgreementsREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Travel may be required, • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential

Job DescriptionCompany Description Derex Technologies Inc specializes in providing IT consulting, staffing solutions and software services. Globally headquartered in Harrison New Jersey since 1996 Derex delivers the highest quality technology professionals and an array of customized IT talent solutions designed to improve productivity and drive results to global clients throughout North America. With over two decades of unparalleled experience, Derex provides supports to its clientele, across such industries as Systems Integration, Banking and Finance, Telecommunications, Pharmaceutical and Life Sciences, Energy, Healthcare, Technology, Transportation, and local and federal Government agencies. Job Description Position: Senior Software Engineer (Healthcare Interoperability) Location: Parsippany, NJ(On-Site) Full Time Job Overview The Senior Software Engineer will be responsible for the full development life cycle—from architecture and design, development, integration, and testing, to deployment, documentation, and support. The role emphasizes healthcare interoperability, FHIR integrations, and secure, scalable, microservices-based applications. This is a hands-on technical role involving both independent and team-based collaboration, requiring excellent communication skills, leadership qualities, and deep technical expertise. Responsibilities • Architect, design, and develop enterprise applications and microservices using Microsoft .NET/.NET Core, ASP.NET Core, C#., • Design and implement FHIR servers and RESTful APIs, ensuring compliance with HL7, SMART on FHIR, and interoperability standards., • Integrate FHIR services with EHR/EMR systems, HL7 v2/v3, and other healthcare data sources., • Implement authentication/authorization frameworks (OAuth2, OpenID Connect, SMART on FHIR) for secure data exchange., • Design and develop ETL processes and healthcare data import/export pipelines (JSON, XML, HL7, FHIR Bundles)., • Ensure applications conform to HIPAA, data security, and OWASP best practices., • Collaborate with Product Managers, Business Analysts, and clients to ensure timely delivery of business requirements and solutions., • Mentor and guide software engineers and support teams while coordinating with offshore/onshore teams., • Participate in Agile (Scrum) ceremonies, CI/CD, testing strategies, and DevOps pipelines., • Provide technical support for business applications post-deployment. Skills & Qualifications • 8+ years of software development experience in enterprise application design and development., • 2+ years of hands-on experience with healthcare interoperability standards (FHIR resources/bundles/search, HL7 v2/v3, SMART on FHIR)., • Strong proficiency in .NET, .NET Core, ASP.NET Core, C#, MVC, Web APIs, ADO.NET, Entity Framework, Dapper., • Experience with FHIR Servers/APIs (HAPI, Firely, Microsoft FHIR Server)., • Expertise in microservices, containerized application development (Docker, Kubernetes), and Azure DevOps/CI-CD pipelines., • Strong database experience with SQL Server performance tuning skills preferred., • Knowledge of SOLID design principles, object-oriented and functional programming., • Strong experience with source control systems (GitHub, TFS)., • Exposure to cloud platforms, particularly Microsoft Azure., • Strong problem-solving, analytical, and communication skills., • Ability to work independently in a fast-paced environment with changing priorities. Key Competencies • Communicates effectively– Attentively listens to others, provides timely and helpful information and is effective in a range of professional settings. Gives and receives feedback in a productive, professional manner. Demonstrates excellent oral and written communication skills., • Manages Ambiguity -Operating effectively, even when things are not certain, or the way forward is not clear. Is flexible in approach and can adapt their approach to meet changing business needs., • Manages complexity -Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems. Has strong organizational skills and can manage multiple activities at once. Has high attention to detail., • Ensures Accountability -Follows through on commitments and makes sure others do the same. Able to work independently as part of a small team. Regards, Manoj Derex Technologies INC Contact : 973-834-5005 Ext 206 Additional Information All your information will be kept confidential according to EEO guidelines.

Job DescriptionJob description Westfield Vet Group; Westfield Location Pharmacy/Lab Technician The Company: Westfield Veterinary Group is a multi-location, multi-doctor practice that offers our employees a wide array of opportunities to grow in this field. We work with each employee to find the coveted “work-life balance.” We pride ourselves for the great care we take with clients and employees alike. We are currently looking for an energetic, enthusiastic, and quick learning individual to join our fast-growing team for full time or part time employment. The Position: Pharmacy/Lab Technician- We are currently looking for an energetic, enthusiastic, and eager individual to join our rapidly growing team. We are a veterinary hospital in need of a pharmacy/lab technician to run our busy, in-house lab, and fill prescriptions for multiple doctors. Attention to detail is a must. Salary is based on experience and knowledge of the field. A quick summary of the requirements for the position can be found below. REPORTS TO: OUTPATIENT SUPERVISOR SUMMARY: Carries out doctor’s orders as requested pertaining to lab work and prescriptions. Reports/documents results as per policy. Maintains all laboratory equipment and logs. Orders supplies as needed. Duties will include but may not be limited to; • Completes all prescriptions as written within appropriate time frames., • Maintains complete and up-to-date pharmaceutical inventory., • Completes and documents all in-house lab work as requested., • Assists in preparation of lab work., • Completes all lab work as requested., • Understanding the purpose of each laboratory test and how sample quality affects results., • Orders laboratory supplies as needed., • Checks and resolves “orphans” daily., • Aid doctors and techs in pharmacy related tasks as requested., • In house lab equipment maintenance/quality control., • Handles all incoming pharmacy calls/voicemails for requests. SKILLS: Ability to multi-task in a fast-paced work environment. Must be detail oriented and have the ability to troubleshoot issues when necessary. Must be patient and respectful to clients and co-workers at all times despite high stress situations. Needs excellent communication skills and to be able to follow tasks to completion. PHYSICAL DEMANDS: Must be able to stand for long periods and frequently lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, and depth perception. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. WORK ENVIRONMENT: The employee may be exposed to zoonotic diseases, noxious fumes or airborne particles; however, PPE will be provided at all times. The noise level in the work environment can be loud. JOB TYPE: Full-time We offer you accrued PTO, and plenty of pet perks for your personal “fur-babies”. We offer health insurance, dental, vision, and 401k, and a variety of opportunities for continuing education in the field. Job Types: Part-time, Full-time Pay: $17.00 - $19.00 per hour Benefits: • 401(k), • 401(k) matching, • Dental insurance, • Employee discount, • Health insurance, • Health savings account, • Life insurance, • Paid time off, • Professional development assistance, • Vision insurance Schedule: • 10 hour shift, • 12 hour shift, • 8 hour shift, • Day shift, • Night shift, • Weekend availability Education: • High school or equivalent (Required) Experience: • Veterinary Technician: 1 year (Preferred) Work Location: In person

Job DescriptionCompany Description • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices., • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description Responsibilities: • Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)., • Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets., • Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements., • Provides input in the design and development of case report forms and clinical databases., • Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs., • Programs for quality checks for clinical study raw data and report the findings to Data Management., • Provides input in the design and development of case report forms and clinical study databases., • MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years., • Experience in providing statistical programming support to early and late phase clinical trials., • Excellent skills in SAS programming and statistical reporting., • Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements., • Familiarity with FDA and ICH regulations and guidelines., • Excellent problem-solving skills., • Good written and verbal communication skills and organizational and documentation skills., • Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc., • Ability to prioritize and multi-task effectively., • Demonstrated positive attitude and the ability to work well with others.Additional Information All your information will be kept confidential according to EEO guidelines.

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Associate Director, Statistics - Immunology provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple disciplines to advance medicines to our patients. This role will work a hybrid work schedule from one of the AbbVie locations: • Lake County, IL, • Provide statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission., • Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans., • Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, and GMA, etc.) to create development strategies for assigned projects., • Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately., • Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff., • Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures., • Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections which foster professional development and promote the reputation of the Statistics Department., • MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field., • High degree of technical competence and excellent communication skills, both oral and written, • Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others, • Able to manage project timeline and quality of deliverables, • Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo, • Have strong leadership skills and experience in working/managing cross-cultural or oversea teams, • Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment., • (SSG) Experience leading safety-related projects (eg, ISS, benefit-risk assessment, signal detection), • (GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionSalary: WHO WE ARE Were an entrepreneur, fast-growing team of projectmanagers, estimators, superintendents, safety and administrative support personnel. As leaders in quality construction management, were committed to providing impeccable service to our clients, a safe work environment for our team, and an opportunity for our employees to grow and enjoy the benefits of work/life balance. Here at ALLY, we cultivate a collaborative environment that values tenacity, attention to detail, and comradery. Since outstanding customer service is our best product, we strive to build long-lasting relationships with our entire customer base. POSITION SUMMARY As a Superintendent reporting to a Sr. Superintendent, the primary purpose of this position is to act as the field representative responsible for on-site project administration, coordination of activities and technical management. You take pride in providing a high-quality product on schedule, consistent with the customers vision and project objectives. RESPONSIBILITIES AND ACCOUNTABILITIES • Act as point of contact with architects, engineers, consultants, local governing officials, and customers on projects in the field., • Act as point of contact, manager, coordinator and motivator to subcontractors and vendors on projects in the field., • Supervise the construction effort in the field to ensure that the project is completed in accordance with design, budget, schedule, and customer objectives. Conduct regular on-site meetings with subcontractors, vendors and others as appropriate with respect to schedule, safety issues, and other matters relating to performance in the field., • Enforce compliance with all project procedures, safety program requirements, and work rules., • Responsible for the timely preparation of field reports (i.e. daily superintendents reports, safety reports, etc.) and distribute to the office., • Ensure the utmost quality of construction throughout a project., • Complete punch list items in a time frame consistent with the customers requirements and the project budget., • Monitor subcontractors progress and ensure man power is adequate to meet project schedule and customer expectations., • Prepare as necessary subcontractor work schedules and provide input to the Project Manager in preparing and updating Project Construction schedules to jointly ensure timely completion., • Verify layout and/or checking of layout by subcontractors and the establishment of initial control lines and grades., • Respond with clarity to subcontractors with respect to questions regarding the performance of their work. Provide documentation and coordinate with Project Manager as appropriate., • Participate in pre-construction planning, including logistics, means and methods, bid and scope reviews, and project estimates., • Maintain an up-to-date set of contract documents on site., • Ensure that subcontractors are maintaining record drawings (red-line as builts) during the course of construction., • Responsible for the organization, the establishment, and maintenance of the onsite field office to project a professional image (organized, clean, signage, etc.)., • Responsible for timely communication with the Project Manager on matters regarding financial issues, safety, construction progress, labor issues, material problems, quality, code issues, etc., • Interface and work harmoniously with respective Project Managers and other ALLY Construction Services personnel., • Manage, oversee, provide training, and act as a mentor to Assistant Construction Superintendents. Perform performance construction evaluations as designated., • Work in harmony with other Construction Superintendents that may be assigned as part of a team on larger projects., • Continue education in areas including OSHA and safety, means and methods, codes, management skills, new technology, etc., • Maintain current Red Cross First Aid and CPR certification., • Maintain a current working knowledge of the permit process in those communities where performing work and communicate information on changes to the office., • Develop an understanding of the roles and responsibilities of all ALLY Construction Services disciplines, including their role as the customer. REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES (KSA) • Possess ALLYs core values:, • Embrace Change (Adaptability)., • Success is No Accident (Safety)., • Go Above and Beyond (Client Service)., • Empowering Success (Accountability)., • Thriving Together (Team Culture)., • Individual must be knowledgeable in all aspects of construction including technology, equipment, methods, field engineering, materials, safety, and scheduling., • Requires outstanding interpersonal skills, attention to detail, and the ability to communicate with a diverse group of individuals., • Working knowledge of Microsoft office (Word and Excel) and Microsoft Project., • Ability to work in a campus setting and corporate style environment., • Pharmaceutical or manufacturing experience (or similar) preferred., • Roofing experience in a campus setting preferred., • Must be a team player. MINIMUM REQUIREMENTS • Preferred BS in Construction Management, or equivalent years of experience., • 5-10 years of experience as a Superintendent in commercial construction., • Eligible to work in the United States., • Have a valid drivers license and properly maintained vehicle with the state minimum mandated levels of auto liability insurance. PHYSICAL DEMANDS/WORK ENVIRONMENT • While performing the duties of this job, the Superintendent is required to sit for long periods of time and is occasionally required to stand; walking within a 400-acre campus; use hands to finger, handle or feel objects, reach with hands and arms; climb stairs and ladders; balance; stoop, kneel, crouch, or crawl; talk or hear; taste or smell. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Assistant Superintendents are required to speak clearly so listeners can understand and hear clearly to understand the speech of another person. In this role and employee may also occasionally lift and/or move up to 20 pounds., • Client site pending, work environments can involve some exposure to hazards or physical risks, which require following basic safety precautions., • Work may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises. WHAT WE OFFER Here at ALLY, we cultivate a collaborative environment that values tenacity, attention to detail, and comradery. We are committed to providing impeccable service to our clients, a safe work environment for our team, and an opportunity for our employees to grow and enjoy the benefits of work/life balance. Since outstanding customer service is our best product, we strive to build long-lasting relationships with our entire customer base. Working at ALLY includes: • Salary range of $85K - $140K, • Paid time off to include vacation, flex (sick/personal) and your birthday!, • Medical, dental, and vision insurance for you and your family dependents (base plan 100% paid), • HSA, Dependent Care, and HRA programs, • 401K Savings/Retirement plan, • Life Insurance (1X of salary paid by ALLY), • Short term disability insurance, • Employee referral program incentives, • Volunteer program, • Tuition reimbursement, • Great team environment with fun, caring, hardworking people We are a Veteran-Owned business and encourage our military service men and women to seek employment with us. We partner with DOD SkillBridge, American Corporate Partners, and have consecutively earned the Federal Governments HireVets.gov Platinum Medallion for several years. Please be sure to call out your honorable service to our country in your email when applying for this role. Interested in joining the ALLY team? Please email us your resume with cover letter and include the position youre applying for in the subject line to . ALLY CONSTRUCTION SERVICES IS AN EQUAL OPPORTUNITY EMPLOYER Applicants are considered regardless of race, color, religion, creed, age, sex, pregnancy, family responsibility, national origin or ancestry, citizenship, marital status, sexual orientation, transgender status, veterans status, genetic information, or status as a qualified individual with a disability or any other protected characteristic in accordance with applicable law.

Job DescriptionQuality Control Analytical Associate IIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. Under the direction of the Manager, QC Analytical Associate II, responsibilities include: • Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations, • Performs maintenance, monitoring, and troubleshooting of pertinent equipment, • Performs and assists in the training of other Quality Control technicians, • Maintains training records and coordinates records retention with Document Control and Training groups, • Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines, • Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable, • Participates in managing QC materials and supplies, • Performs and assists in equipment and method qualification/validation activities as needed, • Performs reagent and media preparation, • Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment, • Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results, • Initiates, investigates, and prepares deviation reports with input from assigned supervisor, • Brainstorms and implements corrective and preventive actions, as and when applicable, • Documents training and execution of shipping test samples to contract laboratories for testing, • Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Communicates effectively with other co-workers, departments, management and clients, • Eventually serves as a lead and/or co-lead for client projects, • Additional tasks as assignedREQUIREMENTS, • BA/BS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred, • Prior industrial experience in cell count methodologies preferred, • Prior academic and/or industrial cell therapeutic experience preferred, • Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry, • Proficient with computer software such as: Microsoft Office, Visio, • Strong written and oral communication skills, • Strong presentational skills preferred, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.Other Information, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The QC Analytical Associate II must be able to work in a laboratory environment for an extended period., • Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hearPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. QC Analytical Associate I is available as well.

Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionMandatory Requirements • Minimum bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field from an accredited institution. Master’s degree preferred., • 4–8 years of analytical experience (preferably at least 3 years in analytical quality assurance)., • Proficient in Microsoft Office and quality applications/software programs., • Strong knowledge and experience with analytical laboratory activities for APIs and drug products, including analytical development and Quality Control (QC)., • Familiarity with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and USP monograph requirements., • Understanding of laboratory equipment operation, qualification, calibration, and software audit trail review (e.g., HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meter, stability chambers)., • Knowledge of FDA and ICH guidance requirements., • Effective interpersonal skills and ability to work in a team environment., • Review and confirm compliance of analytical documents for raw materials, in-process, and finished products., • Monitor and ensure adherence to current Good Laboratory Practices (cGLP) during routine laboratory operations., • Confirm compliance of method validations, verifications, comparison reports, and other study reports., • Prepare and review laboratory investigations (OOS/OOT/Deviations) and ensure compliance., • Verify laboratory chemicals, reagents, and standards for completeness of labeling per SOPs., • Assess and implement Pharmacopoeia changes (editions, supplements, amendments) as they become effective., • Review laboratory audit trails during data review against SOPs., • Coordinate with analytical laboratory teams to provide required documents to cross-functional teams., • Maintain incoming documents with proper tracking, recording, storage, and archival., • Identify system gaps during routine monitoring and report improvement opportunities to the supervisor., • Participate in review of data related to laboratory investigations and incidents to ensure compliance., • Support departmental and cross-functional projects and assignments as directed by management.Education and Experience, • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field required; Master’s preferred., • 4–8 years of analytical experience, with preference for 3+ years in analytical quality assurance., • Proficiency with computer systems, Microsoft Office, and quality applications.Technical Knowledge and Computer Systems Skills, • Operation, qualification, and calibration of laboratory equipment and software audit trail review., • Experience with HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meters, stability chambers, etc., • Knowledge of USP monograph requirements, FDA, and ICH guidance., • Strong documentation and technical writing skills; ability to apply scientific principles and practices., • Ability to work independently and as part of a team in a fast-paced manufacturing environment.Professional and Behavioral Competencies, • Proficient English communication skills (verbal and written)., • Self-starter with initiative to seek training or direction as needed., • Willingness to work assigned shifts (first or second shift); schedules may be Monday to Friday., • Knowledge of good manufacturing and documentation practices preferred., • Self-motivated, organized, and able to handle multiple tasks simultaneously with attention to detail.

Job DescriptionMandatory Requirements • Minimum bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field from an accredited institution. Master’s degree preferred., • 4–8 years of analytical experience (preferably at least 3 years in analytical quality assurance)., • Proficient in Microsoft Office and quality applications/software programs., • Strong knowledge and experience with analytical laboratory activities for APIs and drug products, including analytical development and Quality Control (QC)., • Familiarity with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and USP monograph requirements., • Understanding of laboratory equipment operation, qualification, calibration, and software audit trail review (e.g., HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meter, stability chambers)., • Knowledge of FDA and ICH guidance requirements., • Effective interpersonal skills and ability to work in a team environment., • Review and confirm compliance of analytical documents for raw materials, in-process, and finished products., • Monitor and ensure adherence to current Good Laboratory Practices (cGLP) during routine laboratory operations., • Confirm compliance of method validations, verifications, comparison reports, and other study reports., • Prepare and review laboratory investigations (OOS/OOT/Deviations) and ensure compliance., • Verify laboratory chemicals, reagents, and standards for completeness of labeling per SOPs., • Assess and implement Pharmacopoeia changes (editions, supplements, amendments) as they become effective., • Review laboratory audit trails during data review against SOPs., • Coordinate with analytical laboratory teams to provide required documents to cross-functional teams., • Maintain incoming documents with proper tracking, recording, storage, and archival., • Identify system gaps during routine monitoring and report improvement opportunities to the supervisor., • Participate in review of data related to laboratory investigations and incidents to ensure compliance., • Support departmental and cross-functional projects and assignments as directed by management.Education and Experience, • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field required; Master’s preferred., • 4–8 years of analytical experience, with preference for 3+ years in analytical quality assurance., • Proficiency with computer systems, Microsoft Office, and quality applications.Technical Knowledge and Computer Systems Skills, • Operation, qualification, and calibration of laboratory equipment and software audit trail review., • Experience with HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meters, stability chambers, etc., • Knowledge of USP monograph requirements, FDA, and ICH guidance., • Strong documentation and technical writing skills; ability to apply scientific principles and practices., • Ability to work independently and as part of a team in a fast-paced manufacturing environment.Professional and Behavioral Competencies, • Proficient English communication skills (verbal and written)., • Self-starter with initiative to seek training or direction as needed., • Willingness to work assigned shifts (first or second shift); schedules may be Monday to Friday., • Knowledge of good manufacturing and documentation practices preferred., • Self-motivated, organized, and able to handle multiple tasks simultaneously with attention to detail.

Job DescriptionMandatory Requirements • Minimum bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field from an accredited institution. Master’s degree preferred., • 4–8 years of analytical experience (preferably at least 3 years in analytical quality assurance)., • Proficient in Microsoft Office and quality applications/software programs., • Strong knowledge and experience with analytical laboratory activities for APIs and drug products, including analytical development and Quality Control (QC)., • Familiarity with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and USP monograph requirements., • Understanding of laboratory equipment operation, qualification, calibration, and software audit trail review (e.g., HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meter, stability chambers)., • Knowledge of FDA and ICH guidance requirements., • Effective interpersonal skills and ability to work in a team environment., • Review and confirm compliance of analytical documents for raw materials, in-process, and finished products., • Monitor and ensure adherence to current Good Laboratory Practices (cGLP) during routine laboratory operations., • Confirm compliance of method validations, verifications, comparison reports, and other study reports., • Prepare and review laboratory investigations (OOS/OOT/Deviations) and ensure compliance., • Verify laboratory chemicals, reagents, and standards for completeness of labeling per SOPs., • Assess and implement Pharmacopoeia changes (editions, supplements, amendments) as they become effective., • Review laboratory audit trails during data review against SOPs., • Coordinate with analytical laboratory teams to provide required documents to cross-functional teams., • Maintain incoming documents with proper tracking, recording, storage, and archival., • Identify system gaps during routine monitoring and report improvement opportunities to the supervisor., • Participate in review of data related to laboratory investigations and incidents to ensure compliance., • Operation, qualification, and calibration of laboratory equipment and software audit trail review., • Experience with HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meters, stability chambers, etc., • Knowledge of USP monograph requirements, FDA, and ICH guidance., • Strong documentation and technical writing skills; ability to apply scientific principles and practices., • Ability to work independently and as part of a team in a fast-paced manufacturing environment.Professional and Behavioral Competencies, • Proficient English communication skills (verbal and written)., • Self-starter with initiative to seek training or direction as needed., • Willingness to work assigned shifts (first or second shift); schedules may be Monday to Friday., • Knowledge of good manufacturing and documentation practices preferred., • Self-motivated, organized, and able to handle multiple tasks simultaneously with attention to detail.

Marketing Statement NYC Health + Hospitals is the largest public health care system in the United States. We provide essential outpatient, inpatient and home-based services to more than one million New Yorkers every year across the city’s five boroughs. Our large health system consists of ambulatory centers, acute care centers, post-acute care/long-term care, rehabilitation programs, Home Care, and Correctional Health Services. Our diverse workforce is uniquely focused on empowering New Yorkers. At NYC Health + Hospitals, our mission is to deliver high quality care health services, without exception. Every employee takes a person-centered approach that exemplifies the ICARE values (Integrity, Compassion, Accountability, Respect, and Excellence) through empathic communication and partnerships between all persons. Job Description Purpose of Position: Under direction, serves as a member of senior leadership, participating in the development, establishment, implementation and monitoring of policy application and programs relating to a wide-range of activities that support System goals and objectives. Ensures optimal utilization of resources and compliance with the operating standards of various health care governing and accrediting bodies. Essential Duties and Responsibilities: 1. Participates and assists in the formulation of policy and standards regarding program development and implementation., 2. Assists leadership in the development of policy and translates administrative policy into working programs; assists in formulating interpretation of policy., 3. Assists in the establishment of interdepartmental policies and procedures and identifies and conducts investigations and studies related to major problems in program administration; makes recommendations for improvements and solutions, as appropriate., 4. Participates in monitoring the implementation of administrative and management policy and procedures within the System; maintains liaison with executive directors and staff and provides counsel and assistance., 5. Acts as a principal advisor to the Corporate Officer on confidential or sensitive policy matters., 6. Assists in the development and operational plans of new programs, that support the achievement of pragmatic goals and objectives, from the analytical planning scope through implementation; undertakes research and studies on selected problems of administration and operations., 7. Prepares and/or participates in the development, review, and monitoring of program budget and allocation of funds, and ensures operations run within budgetary guidelines., 8. Prepares fact sheets for the Corporate Officer and secures appropriate materials for use at meetings and conferences., 9. Serves as a liaison among the Corporate Officer, public and private agencies, government or other relevant organizations, and appropriate areas of the System, as necessitated by the planning, development, implementation, and monitoring of specific programs., 10. May represent the Corporate Officer at meetings and conferences., 11. May serve as deputy to the Corporate Officer in specific delegated areas., 12. Performs other related duties, as assigned and/or directed. Minimum Qualifications 1. Master's degree from an accredited college or university in Hospital, Business or Public Administration, Health Care Planning or a related discipline; and five (5) years of progressively responsible experience in health and medical service administration, public administration, personnel and labor relations, finance or an appropriate functional discipline with an emphasis on planning, liaison and inter-organizational relationships or related administrative or managerial functions; or, 2. Bachelor’s degree from an accredited college or university in disciplines, as listed in #1 above; and six (6) years of progressively responsible experience, as described in #1 above; or, 3. Satisfactory equivalent combination of education, training and experience. However, all candidates must have a minimum of a Bachelor’s degree in disciplines, as listed in #1 above. Department Preferences • Experience working for a hospital system and specialized knowledge and experience with multi-disciplinary team collaboration and project management in a clinical environment., • In-depth knowledge of clinical and operational pharmacy practices, including medication therapy management, inventory control, and medication safety protocols, • Expertise in healthcare regulations, including FDA, DEA, and state pharmacy laws and compliance, • Comprehensive understanding of pharmacy operations and systems integration, • Strong leadership skills with the ability to influence at all organizational levels, • Advanced knowledge of strategic planning, financial management, and healthcare operational efficiency, • Proficient in healthcare IT systems such as EPIC and pharmacy management software, • Advanced Excel skills for data analysis and financial forecasting; familiarity with ERP systems, • Proven track record of managing large-scale pharmacy departments and leading system-wide operational initiatives, • Minimum of 10 years of experience in pharmacy operations, with at least 5 years in a senior leadership role, • Doctor of Pharmacy (PharmD) required, MBA or advanced degree in healthcare administration preferred, • Strong academic background with a focus in pharmaceutical sciences, business, or healthcare management, • New York State (NYS) Licensed Pharmacist (RPh) required How To Apply If you wish to apply for this position, please apply online by clicking the "Apply for Job" button.

Position: Analytical Lab Technician Location: Fair Lawn, NJ 07410 Duration: 6 Months Job Type: Temporary Assignment Work Type: Onsite Pay Rate: $30 to $35/hr Overview: TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands. Position Summary: The Process Engineer / Analytical Lab Technician will be responsible for developing and maintaining process control systems to ensure consistent product quality, with a focus on supporting the insourcing of materials and components. This role leads cross-functional efforts to qualify internal processes, validate materials, and transition manufacturing activities from external suppliers. The engineer ensures compliance with GMP, GDP, and regulatory standards while driving process improvements, supporting investigations, and managing documentation throughout the insourcing lifecycle. Key Responsibilities: • Develop, implement, and maintain process control systems to ensure consistent product quality and process efficiency, especially in areas impacted by insourced materials., • Analyze production and supply chain processes to identify bottlenecks, deviations, and improvement opportunities related to the insourcing of components or materials., • Collaborate with Quality Assurance, Product Development, Process Development, and Manufacturing teams to support the insourcing of materials by qualifying internal processes, materials, and suppliers., • Lead and support cross-functional initiatives to transition manufacturing processes or materials from external suppliers to internal operations., • Facilitate root cause analysis during quality investigations, particularly when introducing new internal processes or materials, and incorporate corrective and preventive actions., • Develop and review technical documentation (e.g., batch records, material specifications, validation protocols) to support the qualification and validation of insourced materials., • Coordinate with engineering and project teams to define inspection criteria, material acceptance standards, and validation procedures for internally sourced materials., • Manage documentation routing, review cycles, and project tracking to ensure timely completion of insourcing projects., • Prepare and route documentation for approval, ensuring adherence to Good Documentation Practices (GDP) and applicable regulatory requirements (e.g., FDA, GMP)., • Act as a liaison across internal teams (Manufacturing, Supply Chain, IT, Quality Control, etc.) to ensure seamless integration of insourced materials., • Occasionally interface with external suppliers and partners during the transition period to gather technical data or resolve quality issues., • Support execution of project plans related to material insourcing, ensuring actions, milestones, and deadlines are met., • Provide training for team members on new processes or materials introduced through insourcing efforts., • Ensure compliance with internal SOPs, GMP standards, GDP, and regulatory requirements during all phases of material insourcing and process control. Qualifications: • Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related technical field., • Experience with validation, process transfer, or insourcing/technology transfer is highly preferred., • Should have strong hands-on experience in preparing and analyzing samples and standards using basic laboratory equipment and instrumentation., • Experience with wet chemistry techniques and basic lab instrumentation (e.g., pH meter, balances, UV-Vis, titrations) is required., • Basic understanding of compendial methods (e.g., USP, EP, ACS)., • Strong understanding of GMP, GDP, and FDA quality system regulations., • Demonstrated ability to lead cross-functional projects and manage multiple priorities., • Excellent written and verbal communication skills., • Proficiency in technical writing and documentation control systems. TekWissen® Group is an equal opportunity employer supporting workforce diversity.

QC Manager – Fairfield, NJ Summary: The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. This position will manage the staff to schedule and perform all necessary testing to support manufacturing and release requirements. Responsible for training and personnel development. This is a hands- on position. In addition to managerial responsibilities, this position will be performing analytical testing including wet chemistry, GC, HPLC, etc. as needed Responsibilities: • Lead, coach and manage a team of analysts to ensure data integrity and performance to meet business objectives, • Train and develop analysts, • Formulate, document, and maintain quality control standards and on-going quality control objectives, • Schedule workload to meet release objectives and deadlines, • Review, interpret, analyze and report HPLC/GC/UV/FTIR data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines, • Author analytical methods and SOPs, • Clean, maintain, and troubleshoot HPLC/GC/UV/FTIR instruments, • Develop specifications and analytical methods as required, • Develop analytical methods to support product development projects, • Prepare analytical method validation protocols and reports, • Perform Laboratory Investigations, root cause analysis, CAPA, Change Controls, Validations, Stability Programs, APRs, statistical analysis, environmental monitoring of air, water, and surfaces, as needed., • Manage the outsourcing process of testing to contract laboratories, • Ensure lab safety and manage chemical inventory, • Improve the compliance of the laboratory operations as well improve the efficiency and reduce the cost of the operations, • Perform duties of QC Analyst as needed including HPLC sample preparation and testing and any other testing requirements, • Audit the work of QC Analysts, • Other duties assigned by Management Education: • Bachelor’s degree in a scientific discipline (Chemistry preferred) with a minimum of 5 years’ experience in laboratory management OR Master’s degree in a scientific discipline (Chemistry preferred) with a minimum of 3 years’ experience in laboratory management Experience Requirements: • Experience with Empower 3, • Experience working in an FDA regulated environment, • Experience with GC sample preparation and testing, • Knowledge of USP Monograph testing, analytical method development & validation, • Knowledge of CFR & ICH Regulatory Guidelines, • Knowledge of cGMP processes, lab safety and GDP. Computer Skills: • Proficiency in Microsoft Word, • Proficiency in Microsoft excel, • Proficiency in Empower 3 Other requirements: • Has significant technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory., • Able to perform complex mathematical problems, • In depth knowledge of all laboratory equipment, practices, and procedures, • Demonstrated managerial abilities, • Problem analysis, solving and resolution skills, • Has excellent oral and written skills, • Has excellent interpersonal skills, • Is self motivated, • Has a very high attention to detail, • Has a positive attitude, • Must speak, read, and write in English, • Able to lift 25 pounds, • Able to stand for extended periods Hours: • Standard: 8:30 AM to 5:00 PM, Monday through Friday, • Occasionally: Extended hours and/or Saturday and Sunday may be required as necessary to support manufacturing.

About Us Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey. Evergreen Theragnostics is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Evergreen our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and seek to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. Purpose The Associate Director, Technology Development and Transfer, acts as a technology development and transfer lead in the Tech Ops organization at Evergreen Theragnostics. This position will lead and manage the Manufacturing Science and Technology (MSAT) team at Evergreen. This role will be accountable for the technical work between internal and external stakeholders to ensure design, development, and transfer of robust manufacturing processes for new products and key lifecycle injectable pharmaceutical finished products. This role will be the principal expert and process owner for the end-to-end manufacturing process for injectable pharmaceutical finished products at Evergreen Theragnostics. Ensures processes are designed and validated per applicable cGMPs, Evergreen Theragnostics’ procedures, and that processes are defined consistent with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating /maintaining associated tech development transfer business processes. Key Responsibilities/Essential Functions • Leads technology development and transfer projects for key lifecycle injectable radiopharmaceutical products, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities., • Leads a team of engineers/scientists to execute the development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms., • Leads a team of engineers/scientists to Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies (PCS)., • Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental or authoring plans or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes with internal and external stakeholders., • Partners with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage., • Partners with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Evergreen Theragnostics’ business growth., • Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized manufacturing process., • Leads, motivates, mentors, and develops team members to exceed and meet company goals., • Develops and maintains effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities., • Leads a team of engineers/scientists to own QEs (i.e. Change controls, Investigations, CAPAs, Protocol & report writing), • Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders., • Requires approximately ~20% travel., • Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment., • Reports and takes initiative to correct safety and environmental hazards., • Actively demonstrates Evergreen Theragnostics’ values. Typical Minimum Skills and Experience and Education • Requirements include a B.S. or M.S. in relevant scientific/technical disciplines, advanced degrees (e.g., PhD) or technological certificates preferred but not required., • 5+ years of experience in the radiopharmaceutical industry, including 3+ years focused on technology development and tech transfer activities., • If no prior radiopharmaceutical experience, 10+ years of work experience within pharmaceutical or medical device industry, 5+ years of technology development and transfer experience, within a matrixed pharmaceutical, medical device, or biotechnology organization., • Previous experience working with aseptically filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred. Other Requirements • Subject matter expert (SME) in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology operations. Strong knowledge of global regulatory requirements related to the design and control of these processes., • Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment., • Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product manufacturing processes., • Ability to work within and lead different technical teams., • Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing., • Excellent organizational skills and the ability to successfully manage a multitude of technical projects., • Ability to work in a prompt, complex and changing environment., • Excellent analytical, technical and experiences., • Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills., • Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired., • Experience working with external partners is highly desirable., • Ability to work independently in decision-making and resolution of program obstacles and conflicts., • Keen insight, independent judgment and tactful discretion are required., • Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”., • Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Evergreen Theragnostics’ to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism., • Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Evergreen Theragnostics and CDMO locations.

About Us Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey. Evergreen Theragnostics is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Evergreen our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands.We believe in helping people be their best and seek to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. Purpose The Associate Director, QC, acts as senior leadership for the Quality Control operation at Evergreen Theragnostics. This position will oversee and lead the QC department at Evergreen. This role will be accountable for governing the department in terms of function and responsibility as well as providing technical guidance/decisions (when needed) for the operational levels to ensure an efficient and structured operation that can cater to internal as well as external needs within the organization to deliver quality radiopharmaceutical products. This role will be the primary accountable person for the success of the QC department operations at Evergreen Theragnostics in terms of efficiency, skill retention and compliance. They will ensures processes are designed and compliant per applicable cGMPs, Evergreen Theragnostics’ procedures, and that processes are defined consistently with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. Key Responsibilities/Essential Functions • Design, establish and maintain a standard QC operational structure with assigned roles and responsibilities that can be aligned with the needs of the organization., • Oversee the creation and maintenance of a QC training matrix and program to ensure consistency in execution and retention of capability & skill., • Define specific qualification standards for SMEs and the subsequent qualification processes., • Manage mid-management (supervisors, managers etc) direction to ensure alignment of objectives and completion of deliverables by the department., • Provide technical guidance and decisions to mid-management in order to be able to achieve the required objectives and deliverables., • Design, maintain and defend the internal departmental processes to ensure compliance to cGXP requirements., • Oversee and manage departmental efficiency and proficiency to enable a lean operation., • Review and approve department related protocols, procedures, test methods, and studies as appropriate. Responsible to create, maintain and harmonize key business processes with internal and external stakeholders., • Partner with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage., • Partner with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Evergreen Theragnostics’ business growth., • Partner with site operations to effectively deliver analytical services to meet product release timelines for future product supply. Partner with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized analytical process., • Leads, motivate, mentor, and develops team members to exceed and meet company goals., • Develop and maintain effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities., • Lead assigned operational personnel in owning Quality processes within the required responsibility of the department (i.e. Change controls, Investigations, CAPAs, Protocol & report writing), • Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders., • Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment., • Report and take initiative to correct safety and environmental hazards., • Actively demonstrate Evergreen Theragnostics’ values. Typical Minimum Skills and Experience and Education • Requirements include a B.S. in relevant scientific/technical disciplines, advanced degrees (e.g., MS) or technological certificates preferred but not required., • 2+ years of experience in the radiopharmaceutical industry preferred but not required, • Minimum 10+ years experience in a GMP Quality Control Environment., • Minimum 5+ years experience in people management and conflict resolution., • Minimum 3+ years experience in defending QC operations against FDA and EMEA regulatory inspections., • Previous experience with managing a microbiology department is preferred., • Previous experience working with sterile filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred. Other Requirements • Subject matter expert (SME) in various analytical test methods and analytical technology. Strong knowledge of global regulatory requirements related to the design and control of these processes., • Knowledge of SOPs, cGMPs, GCPs and GLPs and the ability to work and manage within a regulatory environment., • Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product analytical processes., • Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing & testing., • Excellent organizational skills and the ability to successfully manage a multitude of technical projects., • Ability to work in a fast paced, complex and changing environment., • Excellent analytical, technical and experiences., • Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills., • Understanding of FDA and/or EMEA quality and regulatory processes. Prior experience with regulatory filings is highly desired., • Experience working with external partners is highly desirable., • Ability to work independently in decision-making and resolution of program obstacles and conflicts., • Keen insight, independent judgment and tactful discretion are required., • Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”., • Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Evergreen Theragnostics’ to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism., • Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Evergreen Theragnostics and CDMO locations.

OVERVIEW: Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Clinical Lab Specialist. ** JOB ID: 52448 ** JOB TITLE: Clinical Lab Specialist ** LOCATION: Onsite Role 1 Becton Drive Franklin Lakes, NJ 07417 ** DURATION: 12 months + Pay Rate: $40.00/hr. - $44.00/hr. (depending upon experience) JOB RESPONSIBILITIES: • This laboratory-based position will provide input to design, evaluation, execution and reporting for safety and efficacy of new or modified in-vitro diagnostic devices, as well as provide innovative ideas cross functionally with other business units. Possess a technical competence and works with human blood in clinical laboratory disciplines such as phlebotomy, chemistry, hematology, coagulation, urinalysis, point of care and capable operation of numerous instrument platforms. Responsible for managing clinical laboratory studies and complaint testing through a variety of clinical testing methods. Knowledge and expertise demonstrating safety and efficacy of new or modified in-vitro diagnostic devices, as well provide innovative ideas outside of the core business. Develop/implement new testing methodologies in collaboration with R&D. Responsible for understanding product design, function and able to apply quality and regulatory standards. Capable of performing Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab. Utilizes technical/scientific judgment to resolve technical issues. Works with many different disciplines (manufacturing, marketing, quality, regulatory, etc.), materials, products and processes in the development of core clinical laboratory and outside the core clinical laboratory products and services. Possesses a strong commitment to quality and continuous improvement., • Provides input to and conducts scientific investigations in areas of considerable scope and complexity. Explores, identifies and recommends solution, concepts and principles., • Adapts methodologies as needed for areas related to the core clinical laboratory., • Conducts clinical testing, maintains laboratory instrumentation/reagent test systems and inventory to strategically align with the priorities within the lab and business objectives., • Implements and documents Quality Assurance and Quality Control procedures as they pertain to instrumentation and methodology., • Conducts instrument verification per CLSI guidelines, assists with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP., • Performs Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab., • Keeps current in the field of Clinical Laboratory Science through review of technical literature, participation in continuing education via webinars/symposia and or customer visits., • Trains new associates (permanent or temporary) on the Laboratory workflow., • Senses and monitors trends in laboratory practice and utilizes this information to recommend new projects and influence ongoing projects., • Participates in development of the clinical strategy for all client IDS- Specimen Management products and is responsible for generation of scientific and clinical information to support product conceptualization, feasibility and development., • Responsible for scientific integrity and clinical accuracy of all claims and communications made concerning specific PAS products globally., • Responsible for management of individual focused projects to complex projects involving multiple internal clinical studies/evaluations., • This position provides support from a base of clinical experience and knowledge to resolve customer complaints through clinical investigations., • This position will also provide support to guide and implement innovation, product development, clinical testing, manufacturing, and post market surveillance via interfacing with R&D and GCD to insure successful and timely completion of projects. JOB REQUIREMENTS: • Education: BA/MA in Clinical Laboratory Science or Medical Technology, Biology Life Sciences or health related field required., • MT/MLT CLS (ASCP) or equivalent experience in a Research environment, • 5 years+ experience in the Clinical Laboratory environment, • Strong working knowledge of clinical laboratory science, • Excellent verbal and written communications skills, • Awareness/basic knowledge of GCP/GLP and ISO regulations, • Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab, • Phlebotomy is a plus, • Experience with human blood specimen collection products, • Product Trouble shooting as it relates to clinical results, • Strong computer skills, • Strong project planning and budget management skills, • Develop/implement new testing methodologies in collaboration with R&D, • Proven understanding of clinical laboratory testing, blood collection, Urinalysis, POC and LIS/LIMS systems and an ability to apply knowledge to innovative concepts/projects beyond the core clinical laboratory I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you. Recruiter Name: Lalit Malgotra Title: Lead Recruiter Email ID: Company Overview: Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally: as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with a service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward. Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Applicants with criminal histories are considered in a manner that is consistent with local, state and federal laws.