Pharmaceutical quality assurance jobs in New York, NYCreate job alerts

Job Description Jamaica Hospital Medical Center a renowned Queens, New York Community based hospital and Level 1 Treatment Center currently seeks an Oncology Clinical Pharmacy Specialist for an immediate full-time day shift opportunity. Our ideal candidate will have a minimum Board Certification in Oncology (BCOP), with at least 4 years of experience in Oncology management. A PGY 1 Residency and a PGY2 residency in Oncology is preferred, or equal clinical experience in Oncology with BCOP. Selected candidate will provide clinical pharmacy services for inpatient and outpatient hematology/oncology medication management; and be responsible for the management of adult patients receiving ambulatory chemotherapy as well as patients with oncology related admissions. He/she will actively participate in committee work and projects to advance and elevate pharmacy practice and investigational drug services related to oncology studies. JOB RESPONSIBILITIES • Collaborating with inter-professional team to enhance communication, coordinate care, and improve patient satisfaction., • Prospectively evaluating all drug therapy for appropriate indications, dosage, drug interactions, and drug allergies; monitors the patients’ pharmacotherapeutic regimen for effectiveness and ADEs and intervenes as needed., • Identifying ADEs and assisting in their management and prevention, reporting and developing process improvements to reduce drug errors and preventable ADEs., • Providing pharmacokinetic monitoring when a targeted drug is prescribed., • Coordinating with stakeholders to ensure timely access to medications., • Partnering with patients to determine the most appropriate sources for their medication needs and referring patients to appropriate programs and resources., • Assisting in insurance related issues and working with coordinators of prior medication authorizations., • Providing drug therapy related education to Oncology team members., • Documenting clinical activities that include, but not limited to, disease state management, general pharmacotherapeutic monitoring, pharmacokinetic monitoring, ADEs, education, and other patient care activities., • Providing didactic lectures to health professional residents and students in oncology pharmacology and therapeutics, where applicable, • Acts as a liaison between pharmacy, nursing, and the medical staff to educate health professionals regarding current drug-related procedures, policies, guidelines, and pathways., • Developing drug monographs on issues related to chemotherapeutic and supportive care medications., • Implementing and maintaining departmental policies and procedures related to safe and effective use of drugs., • Collaborating with nursing, medical staff, and hospital administration to prepare for Joint Commission surveys and responding to any deficiencies identified., • Providing consultation to hospital committees, such as Pharmacy Therapeutics and Nutrition, when oncology pharmacotherapy issues are discussed., • Identifying how drug costs may be minimized through appropriate use of chemotherapeutic medications and through implementation of cost-containment measures., • Participating in quality assurance programs to enhance pharmaceutical care., • Developing order sets and treatment plans within the Electronic Medical Record and the Clinical Oncology Application, • Precepting student pharmacists interested in an Oncology rotation., • Participating in investigational drug services related to oncology studies, as needed. QUALIFICATIONS · Doctor of Pharmacy Degree from an accredited College of Pharmacy or equivalent · Board Certification in Pharmacotherapy (BCPS) or Board-Certified Oncology Pharmacist (BCOP) preferred. · Completion of PGY1 Pharmacy Practice residency and 3-6 years oncology experience preferred. · PGY2 Specialty residency in Adult Oncology or equivalent Adult Oncology experience and minimum 2 years of clinical experience preferred. · New York State Pharmacist License, or eligibility to sit for the exam. SALARY: $150K - $170K DOE Plus, Fully Benefits & PTO FOR IMMEDIATE CONSIDERATION FORWARD RESUME TO: CLINICAL PHARMACY DIRECTOR Company DescriptionRecognized as one of the leading hospitals in Queens New York since 1891, Jamaica Hospital Medical Center has proudly served the community for over a century. Today, we continue to meet the needs of our diverse population by providing a wide range of quality healthcare services. Our mission is “To serve our patients and the community in a way that is second to none.” Or vision is, “To be the premier integrated healthcare delivery system by providing the highest quality, most cost-effective service, which is accessible and sensitive to all.”Recognized as one of the leading hospitals in Queens New York since 1891, Jamaica Hospital Medical Center has proudly served the community for over a century. Today, we continue to meet the needs of our diverse population by providing a wide range of quality healthcare services.\r\nOur mission is “To serve our patients and the community in a way that is second to none.”\r\nOr vision is, “To be the premier integrated healthcare delivery system by providing the highest quality, most cost-effective service, which is accessible and sensitive to all.”

Job Description Supervisory Compounding Pharmacist Location: Brooklyn, NY Job Type: Full-Time role Schedule: Monday to Friday 8:30 AM – 5:30 PM (Flexible) Compensation: $76 - $85 /hour (based on experience) We are seeking a skilled, detail-oriented, and passionate Compounding Pharmacist to join our team at Medcals Lab. Our facility operates in full compliance with USP <795>, <797>, and <800> standards, ensuring the highest quality and safety in compounding practices. In this role, you will collaborate closely with healthcare professionals, patients, and pharmacy staff to deliver customized medications that make a real difference in patient outcomes. Key Responsibilities: • Compounding Expertise: Prepare both sterile and non-sterile compounded medications according to prescriptions and regulatory guidelines., • Managing staff and workflow, • Order verification and review, • Customer service, counseling, • Customization: Develop tailored formulations to meet unique patient needs., • Quality Assurance: Maintain strict adherence to USP standards, state regulations, and internal SOPs., • Inventory Management: Monitor, order, and manage compounding supplies and equipment., • Patient Care: Provide consultations to ensure proper medication usage and address patient questions., • Team Collaboration: Work closely with pharmacy staff and healthcare providers to ensure safe, effective, and timely medication delivery., • Compound 360 software documentation, • Education: Bachelor’s in Pharmacy (B.S. Pharm) or Doctor of Pharmacy (Pharm.D.)., • Licensure: Valid and active pharmacist license in [State], in good standing with the State Board of Pharmacy., • Experience: Strong knowledge of compounding principles, aseptic techniques, and compounding equipment., • IV compounding experience with USP <797> preferred. At Medcal Pharmacy, we pride ourselves on providing personalized pharmaceutical solutions that improve lives. This is a per diem position, offering flexibility and the opportunity to work with a dedicated, supportive team while practicing at the highest standards of pharmacy care. Company DescriptionWe specialize in fertility medications and offer sterile and non-sterile compounding. UPS standards 795,797, and 800We specialize in fertility medications and offer sterile and non-sterile compounding. UPS standards 795,797, and 800

Job Description Clinical Trial Recruiter RCT 101/100 Job Type: Full Time and Part Time positions available Seeking individuals for Clinical Trials Recruiter position in our Fairfield, NJ facility. CPTC provides testing and consultation services to the pharmaceutical, cosmetic, personal care, medical device and household product industries. Job Type: Full Time/Part Time: Base Hours vary MINIMUM QUALIFICATION REQUIREMENTS To perform this job, an individual must be able to perform each essential duty satisfactorily, and meet the educational and experience requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES • Review database for panelists with matching inclusion/exclusion criteria to upcoming clinical trial protocols., • Contact potential subjects and discuss clinical trial requirements and availability to participate, • Ensure compliance with protocols, and standard operating procedures, • Data entry of subject data into database · High School diploma / GED required · General Office Equipment Skills · 2 years clerical experience preferred COMMUNICATION SKILLS • Computer skills: MS Word and Excel required, • Organizational, analytic, and problem-solving skills, • Attention to detail; ability to maintain confidentiality PHYSICAL REQUIREMENTS On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch; talk, hear, and smell. Specific vision requirements including reading of written documents, visual inspection of documents and use of computer monitor screen frequently. This position entails repetitive motion with keyboard and mouse. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law. Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Mass Spectrometry Laboratory Scientist The Mass Spectrometry Laboratory Scientist is responsible for independently executing established LC-MS and GC-MS analytical methods, processes, and procedures for the preparation and analysis of samples from OTC drug, Pharmaceutical, and Cosmetic industry clients. Reports to: Mass Spectrometry Laboratory Manager Collaborates with: Chemistry Laboratory and Quality Assurance Associates ROLES & RESPONSIBILITIES • Operate, maintain, and troubleshoot LC-MS and GC-MS mass spectrometry instruments, • Perform routine sample preparation for LC-MS and GC-MS analysis (extractions, digestions, derivatizations, dilutions)., • Conduct quantitative and qualitative analysis of pharmaceuticals and other compounds., • Participate in development and validation of MS-based analytical methods following regulatory and scientific guidelines (ICH, FDA, USP)., • Process, interpret, and report experimental data with accuracy and clarity., • Ensure data integrity and compliance with GLP/GMP, 21 CFR Part 11, and internal SOPs., • Maintain lab documentation (logbooks, electronic records, method development reports)., • Collaborate with cross-functional teams., • Assist in instrument qualification, calibration, and preventive maintenance., • Stay current with advances in mass spectrometry technologies and workflows. TECHNICAL SKILLS • Strong knowledge of LC-MS and GC-MS operation and applications. Experience with LC-MS/MS a plus., • Broad experience in sample preparation techniques for LC-MS and GC-MS analysis of small molecules., • Familiarity with MS software for data acquisition and analysis. Familiarity with Waters and Agilent instrumentation and software a plus., • Thorough understanding of chromatographic separation., • Experience with impurity and/or contaminant profiling methods such as nitrosamines, extractables & leachables, pesticides, residual solvents, API impurities, and/or PFAS desirable, • Strong understanding of analytical method development and validation principles. REQUIREMENTS • PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields may be preferred., • Masters degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields with 4-6 years experience or Bachelors degree with 6-10 years hands-on experience with LC-MS and GC-MS instruments and methods may be accepted., • Hands-on experience in sample analysis and instrument operation required., • Experience working in an FDA-regulated environment, preferably cGMP highly desired, • Must be permitted to work in the US., • This is a 100% onsite position.

Participate in Quality Assurance programs, the Pharmaceutical Services Committee, and any other facility committee or program that affects the medication pass and seeks to improve the performance and accuracy of the medication process. Participate and cooperate with any facility surveys (inspections

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 DescriptionJob Title: Compliance Investigator Job Description We are seeking a dedicated Investigator responsible for writing and completing investigations and deviations from both a compliance and operations perspective. This role involves conducting root cause analysis, overseeing the full lifecycle of investigations, and ensuring adherence to GMP standards. Responsibilities • Write and complete investigations and deviations to ensure compliance with manufacturing and GMP standards., • Conduct root cause analysis and manage the full lifecycle of investigations independently., • Interview manufacturing personnel and communicate effectively with vendors regarding investigations., • Own and author deviations, determining causes and preventative actions for deviations, non-conformances, OOS, OOT, field complaints, and environmental excursion investigations., • Drive investigations to true root cause using appropriate tools and benchmark industry standards., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations at different stages to meet compliance deadlines and product release dates efficiently., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify improvement opportunities., • Develop training materials and educate personnel on writing problem statements and using root cause analysis tools., • Champion CAPA plans and their implementation., • Provide communication plans for ongoing deviations and CAPA's., • 2-3 years of experience writing and reviewing deviations and investigations., • Experience working within a pharmaceutical company supporting manufacturing., • Experience within a quality assurance team., • Strong skills in root cause analysis and CAPA., • Bachelor's degree in a related scientific field., • Experience with biologics, aseptic techniques, and manufacturing environments., • Technical writing proficiency., • Experience using e-Quality Management Systems. You will work closely with a team of QA/QC professionals and cross-functionally with the manufacturing team. The team currently consists of 2-3 other investigators. You will work on the first shift, Monday through Friday, with an 8am or 9am start time, across two sites located a block away from each other. The role offers opportunities for growth, a positive work culture, and the satisfaction of contributing to saving patients' lives. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. Pay and Benefits The pay range for this position is $45.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Sep 17, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

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 Version 1 has celebrated over 28 years in Technology Services and continues to be trusted by global brands to deliver solutions that drive customer success. Our expertise enables our customers to navigate the rapidly changing Digital-First world we live in. We foster strong partnerships with leading technology giants including Microsoft, AWS, Oracle, Red Hat, OutSystems, Snowflake, ensuring that our customers are provided with the highest quality solutions and services. We’re an award-winning employer reflecting how our employees are at the very heart of Version 1 and what we do: • Premier AWS, Microsoft & Oracle partner, • 10+ years as a Great Place to Work in Ireland & UK As a Business Development Director, you will proactively engage with Private Sector global manufacturing organisations (based in the United States to understand their specific business challenges, needs and requirements. This includes process, discrete, automative, technology, and heavy industry manufacturers but excludes pharmaceutical manufacturing. You will identify and shape client engagements to position Version 1 to uniquely meet these needs and the lead Version 1’s efforts to secure and deliver profitable business. You will prospect for business both independently and via or with partners to maximise lead generation, grow our business and build Version 1’s brand and reputation in our target markets. You will be a self-starter comfortable having c-suite level conversation to develop relationships that will deliver short- and long-term growth for Version 1. Responsibilities: • Prospect for, develop new business pipeline, and secure business with target Private Sector clients through a combination of new logo and new growth with existing customers., • Lead small through to large scale sales opportunities (7/8 figure sales opportunities) whether self-generated by yourself, identified by our Commercial Growth team or introduced by one of our strategic partners., • Lead the development and delivery of client facing presentations, proposals and tender responses, working the wider Version 1 team including Partner Managers, Commercial Operations, Delivery Management and Capability Units., • Developing trusted and impactful relationships with channel partners (including AWS, MS, Oracle, Snowflake, Outsystems, Redhat, etc) to build effective collaborations, pipeline and new business., • Communicating effectively the value of Version 1’s products and services via lead generation, participation in events, client presentations and clearly written proposals, • Robustly qualify all customer sales opportunities to ensure they are winnable with clearly defined win strategy and differentiation., • Managing pipeline, financial forecasting, activity tracking, strategic and territory management to achieve financial KPIs, • Establish long-term profitable relationships with senior-level key stakeholders in strategic and designated growth accounts., • Collaborating cross-functionally with colleagues within Version 1 to develop sales and marketing strategies to promote Version 1’s product and services, • You will be leading the execution of contracts awarded to Version 1 – client engagement, commercials, contracting, delivery practice engagement, and project mobilisation.Qualifications, • Established and mature network within the Manufacturing sector which includes deep, long-term relationships that will yield new business growth., • Display solid working history of solution based consultative selling to both technology and business stakeholders in Private Sector organisations up to CxO level., • Be knowledgeable of and able to converse with senior stakeholders on key business-technology related topics relevant to process, discrete, and automotive manufacturing, heavy industry, and underlying systems and applications, e.g. MES, SCADA, PLC and factory-floor., • Have proven track record in leading successful digital transformation sales engagements to Private Sector firms incorporating technologies and services across Applications, Data, AI and Cloud., • Demonstrate tenacity, drive and individual ambition to be successful in a high-growth, fast paced sales environment., • Demonstrate a consistent track record of achieving and exceeding sales targets in a highly competitive environment (winning against large global systems integrators, major consultancies and large off-shore consultancies), • Demonstrate the ability to develop and explain compelling value propositions based on technology and related services to senior level stakeholders., • Have experience of building and maintaining trusted client relationships which can be leveraged into your new role with Version 1., • Influencing skills: the ability to form and lead teams operating across a highly matrixed organisation, ensuring customer focused deliverables are delivered on time, coherently and with high quality., • Strong communication and interpersonal skills, with the ability to engage at all levels across an organisation internally and externally, • Good commercial awareness and sound understanding of project and business dynamics., • Reporting to the Global Head, Manufacturing, Engineering and Construction sector, experience in similar asset-heavy, capital-intensive industries e.g. construction, would be an advantage. Additional Information Why Version 1? At Version 1, we believe in providing our employees with a comprehensive benefits package that prioritises their wellbeing, professional growth, and financial stability. • Share in our success with our Quarterly Performance-Related Profit Share Scheme, where employees collectively benefit from a share of our company's profits., • Strong Career Progression & mentorship coaching through our Strength in Balance & Leadership schemes with a dedicated quarterly Pathways Career Development programme., • Flexible/remote working, Version 1 is tremendously understanding of life events and people’s individual circumstances and offer flexibility to help achieve a healthy work life balance., • Financial Wellbeing initiatives including; Pension, Private Healthcare Cover, Life Assurance, Financial advice and an Employee Discount scheme., • Employee Wellbeing schemes including Gym Discounts, Bike to Work, Fitness classes, Mindfulness Workshops, Employee Assistance Programme and much more. Generous holiday allowance, enhanced maternity/paternity leave, marriage/civil partnership leave and special leave policies., • Educational assistance, incentivised certifications, and accreditations, including AWS, Microsoft, Oracle, and Red Hat., • Reward schemes including Version 1’s Annual Excellence Awards & ‘Call-Out’ platform. #LI-PS1

Job DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • 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 team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on 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.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 Description About Tonix* Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. Position Overview The Vice President (VP), Clinical Development is a leadership role responsible for guiding Tonix Pharmaceuticals' clinical development programs. Reporting directly into the Chief Medical Officer (CMO), this position will provide strategic oversight to ensure excellence in clinical research, regulatory interactions, and product approvals within Tonix's core therapeutic areas including central nervous system (CNS) disorders, Transplant, Immunology and Oncology. Essential Duties • Define and lead the company’s clinical development strategy, ensuring alignment with corporate vision and regulatory expectations with Tonix’s pipeline and therapeutic focus., • Oversee the planning, design, execution, and completion of clinical trials (Phases I-IV), ensuring efficiency, scientific rigor, and compliance with regulatory standards, timelines, and budgets. Oversee the development of clinical protocols, investigator brochures, statistical analysis plans, and other critical regulatory documents. Collaborate with clinical operations to ensure the quality and integrity of clinical data; and support scientific communications and publications regarding pipeline programs. Maintain a strong focus on innovation in clinical trial design, patient-centric approaches, and biomarker-driven strategies., • Oversee the selection and management of CROs, academic partnerships, and external collaborations to optimize clinical trial execution., • Drive a culture of operational excellence, regulatory compliance, quality assurance, adherence to GCP guidelines, ethical considerations, and scientific integrity across Clinical Development., • Represent the company at key scientific conferences, industry consortia, and investor presentations to enhance corporate reputation., • Provide leadership to the Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams., • Provide medical and scientific leadership to cross-functional teams, integrating insights from medical affairs, regulatory affairs, and commercial teams to drive program success., • Partner with R&D, Medical Affairs, Commercial, and Business Development teams to align clinical development with broader corporate objectives., • Serve as the clinical development leader for assigned pipeline programs in interactions with global regulatory agencies (FDA, EMA, etc.), ensuring effective engagement, submission strategies, and post-approval commitments; lead the preparation and review of regulatory submissions, including INDs, NDAs, BLAs, and CTAs., • Cultivate and maintain strong relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations specific to the products and indications for the programs led., • Build, mentor, and lead high-performing teams, fostering a culture of excellence, innovation, and accountability., • Strong ability to build and sustain meaningful relationships with KOLs, regulatory bodies, and external strategic partners., • Exceptional leadership, mentorship, strategic planning, and operational management skills., • MD or DO, expertise and experience in rheumatology or immuno-oncology strongly preferred., • Experience: 10-15 years of relevant experience, demonstrating progressive leadership in clinical development within pharmaceutical or biotechnology companies, including prior experience serving at the Senior Director level or above in Clinical Development organizations., • Demonstrated success in leading clinical development programs., • Regulatory Compliance: Extensive experience with regulatory interactions, submissions, and product approvals. Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $250,000 to $350,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

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 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 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 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 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 DescriptionCompliance Investigator, Clinical ManufacturingAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Compliance Investigator, Clinical Manufacturing 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, field complaints and 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., • Champion 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 degree in a Quality/ Process related field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • 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., • Quality Systems Training (Deviation/CAPA)Working Environment 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. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. 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 DescriptionCompany Description Version 1 has celebrated over 28 years in Technology Services and continues to be trusted by global brands to deliver solutions that drive customer success. Our expertise enables our customers to navigate the rapidly changing Digital-First world we live in. We foster strong partnerships with leading technology giants including Microsoft, AWS, Oracle, Red Hat, OutSystems, Snowflake, ensuring that our customers are provided with the highest quality solutions and services. We’re an award-winning employer reflecting how our employees are at the very heart of Version 1 and what we do: • Premier AWS, Microsoft & Oracle partner, • 10+ years as a Great Place to Work in Ireland & UK As a Business Development Director, you will proactively engage with Private Sector Pharmaceutical, Life Sciences & Healthcare global organisations based in the United States to understand their specific business challenges, needs and requirements. You will identify and shape client engagements to position Version 1 to uniquely meet these needs and the lead Version 1’s efforts to secure and deliver profitable business. You will prospect for business both independently and via or with partners to maximise lead generation, grow our business and build Version 1’s brand and reputation in our target markets. You will be a self-starter comfortable having c-suite level conversation to develop relationships that will deliver short- and long-term growth for Version 1. Responsibilities: • Prospect for, develop new business pipeline, and secure business with target Private Sector clients through a combination of new logo and new growth with existing customers., • Lead small through to large scale sales opportunities (7/8 figure sales opportunities) whether self-generated by yourself, identified by our Commercial Growth team or introduced by one of our strategic partners., • Lead the development and delivery of client facing presentations, proposals and tender responses, working the wider Version 1 team including Partner Managers, Commercial Operations, Delivery Management and Capability Units., • Developing trusted and impactful relationships with channel partners (including AWS, MS, Oracle, Snowflake, Outsystems, Redhat, etc) to build effective collaborations, pipeline and new business., • Communicating effectively the value of Version 1’s products and services via lead generation, participation in events, client presentations and clearly written proposals, • Robustly qualify all customer sales opportunities to ensure they are winnable with clearly defined win strategy and differentiation., • Managing pipeline, financial forecasting, activity tracking, strategic and territory management to achieve financial KPIs, • Establish long-term profitable relationships with senior-level key stakeholders in strategic and designated growth accounts., • Collaborating cross-functionally with colleagues within Version 1 to develop sales and marketing strategies to promote Version 1’s product and services, • You will be leading the execution of contracts awarded to Version 1 – client engagement, commercials, contracting, delivery practice engagement, and project mobilisation.Qualifications, • Established and mature network within the Pharmaceutical, Life Sciences & Healthcare sector which includes deep long relationships that will yield new business growth., • Display solid working history of solution based consultative selling to both technology and business stakeholders in Private Sector organisations up to CxO level., • Be knowledgeable of and able to converse with senior stakeholders on key business-technology related topics relevant to a given Private Sector industry (manufacturing, retail, pharma, logistics and more)., • Have proven track record in leading successful digital transformation sales engagements to Private Sector firms incorporating technologies and services across Applications, Data, AI and Cloud., • Demonstrate tenacity, drive and individual ambition to be successful in a sales environment., • Demonstrate a consistent track record of achieving and exceeding sales targets in a highly competitive environment (winning against large global systems integrators, major consultancies and large off-shore consultancies), • Demonstrate the ability to develop and explain compelling value propositions based on technology and related services to senior level stakeholders., • Have experience of building and maintaining trusted client relationships which can be leveraged into your new role with Version 1., • Influencing skills: the ability to form and lead teams operating across a highly matrixed organisation, ensuring customer focused deliverables are delivered on time, coherently and with high quality., • Strong communication and interpersonal skills, with the ability to engage at all levels across an organisation internally and externally, • Good commercial awareness and sound understanding of project and business dynamics. Additional Information Why Version 1? At Version 1, we believe in providing our employees with a comprehensive benefits package that prioritises their wellbeing, professional growth, and financial stability. • Share in our success with our Quarterly Performance-Related Profit Share Scheme, where employees collectively benefit from a share of our company's profits., • Strong Career Progression & mentorship coaching through our Strength in Balance & Leadership schemes with a dedicated quarterly Pathways Career Development programme., • Flexible/remote working, Version 1 is tremendously understanding of life events and people’s individual circumstances and offer flexibility to help achieve a healthy work life balance., • Financial Wellbeing initiatives including; Pension, Private Healthcare Cover, Life Assurance, Financial advice and an Employee Discount scheme., • Employee Wellbeing schemes including Gym Discounts, Bike to Work, Fitness classes, Mindfulness Workshops, Employee Assistance Programme and much more. Generous holiday allowance, enhanced maternity/paternity leave, marriage/civil partnership leave and special leave policies., • Educational assistance, incentivised certifications, and accreditations, including AWS, Microsoft, Oracle, and Red Hat., • Reward schemes including Version 1’s Annual Excellence Awards & ‘Call-Out’ platform. #LI-PS1

Job Description Summary The Quality Validation Specialist will be responsible for ensuring that finished products meet company standards through inspecting, assessing, and testing of products, integrations, and implementations of new equipment and processes. The candidate will support the day-to-day activities pertaining to the lab, customer complaints, environmental monitoring, and validations (equipment, cleaning, process and products). The ideal candidate must understand lab procedures and process validation strategies. The position will report directly to the Lab Supersivor with oversight by the QA Manager. This role offers responsibility, variety and the satisfaction that your role makes a real impact on our success Responsibilities • Assist QA management with implementing various quality systems (SQF, Organic, Kosher, RSPO, UTZ, etc.), • Assist with lab testing, sample collection, sensory evaluation, shelf-life retention monitoring, • Communicate corrective actions to suppliers/vendors., • Assist in implementation of corrective actions required as a result of an audit or internal finding, • Communicate nonconforming products to appropriate personnel., • Write technical reports and supporting documentation such as deviation, CAPAs, reports, testing protocols, and trend analyses preventative/corrective actions. Ensure timely closure of investigations., • Participate in internal audits for compliance with SOPs, GMPs, and regulations., • Participates actively in technology transfer, method qualification and validation., • Experienced with GFSI and HACCP Scheme (SQF, BRC), • HACCP and PCQI Certified is not required but a plus, • 1-2 years of relevant work experience in a medical device, pharmaceutical, or food processing industry field., • Knowledge of Regulations and Standards: Familiarity with relevant regulations and standards, such as cGMP (Current Good Manufacturing Practices) GMP experience in manufacturing environment., • Working knowledge of safety rules, regulations and training., • Bilingual (Spanish/English), • Good Communication skills: Ability to communicate effectively with technical and non-technical personnel., • Technical Writing: Intermediate to advance, • Problem-Solving Skills: Ability to identify and resolve issues related to validation activities., • Strong working knowledge of Microsoft Excel, Microsoft Word, Microsoft PowerPoint and Microsoft Outlook, • The ability to solve practical problems or issues and report in a high level, • Ability to work in a team environment, • Scientific Background: Typically requires a bachelor's degree in a scientific field, such as biology, chemistry, or engineering., • Technical Proficiency: Familiarity with laboratory equipment and validation techniques, methodologies., • Analytical Skills: Strong analytical skills to evaluate data and identify trends.

Job DescriptionJob Title: Quality Assurance ManagerJob Description The Quality Assurance Manager 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 standards. Responsibilities • Mentor and lead 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., • Work with the Engineering and Production Managers to lead continuous improvement activities and procedures to ensure efficient and compliant processes., • Implement new procedures and policies 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., • Administer Employee Performance Reviews and Disciplinary Actions for all quality assurance and quality control., • Create and implement KPIs for quality assurance and quality control., • Ensure compliance with all company control documents as it relates to quality assurance and quality control (SOPs, Guidelines, Process Descriptions, and Forms and Checklists)., • Ensure all employees work according to the company’s cGMP and ISO standards., • Develop and communicate a monthly business review which includes performance and trending information., • Create and maintain performance indicators, quality benchmarks, and measure performance in the quality assurance department., • Oversee all QA testing, performance indicators, and benchmarks for all projects., • Drive quality certifications and take the lead on all audits (ISO, Customer, Internal)., • Renew and maintain all documentation regarding certifications and other company licenses concerning quality control and assurance., • Develop and maintain quality improvement policies and procedures that meet legal and company requirements and standards., • Conduct quality audits of vendors and suppliers to ensure conformity., • Develop complaint investigation procedures, document and make recommendations for corrective actions, and ensure proper follow-up., • Investigate and provide support for recall and return of non-conforming raw material., • Track, review, and approve payroll for all quality assurance personnel and manage overtime., • Develop an annual budget and forecasts and explain significant variance between actual and budgeted/forecasted figures., • Oversee the daily functions of all quality assurance and quality control personnel, ensuring all resources are allocated effectively and efficiently., • Ensure the proper flow of information to all quality assurance and quality control staff., • Act as a liaison between different departments to provide status updates on projects or jobs., • Ensure that employees adhere to proper company and Quality standards when carrying out their job duties., • 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 affect safety., • Experience with ERP/MRP systems, preferably SAP., • Intermediate to advanced level of computer knowledge in the Microsoft Office Suites/MS 365., • Ability to read, analyze, and interpret technical procedures, manuals, and manufacturing documents including financial data. This position requires the individual to be onsite 5 days per week. The successful candidate will report directly to the President of the company and work alongside engineering and operations management. The team consists of 9 quality professionals who will report into this person. The company is an internationally active, high-tech label manufacturer, operating with over 1,500 employees across three locations. The US operations are currently headquartered in Blauvelt, NY with plans to relocate to Chestnut Ridge, NY within the next two years. The new facility will offer increased production, warehousing, and shipping capacity, and include a training center for employees to enhance their skills and test new innovations. Job Type & Location This is a Permanent position based out of Blauvelt, New York. Pay and Benefits The pay range for this position is $135000.00 - $150000.00/yr. PTO Vacation, Sick Time (NYS), benefits medical, health, dental, 401K Workplace Type This is a fully onsite position in Blauvelt,NY. Application Deadline This position is anticipated to close on Sep 25, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job DescriptionQuality Assurance Manager 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 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, • Experience 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 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 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, Supply Planning position is responsible for the operations and strategic design of the US Medical Device & Aesthetics businesses global supply planning organization which support very significant revenue streams for Medical Device & Aesthetics businesses. Achieving the revenue goals are critical to AbbVie’s top line revenue goals and strategic imperatives. Responsibilities include translating demand into inventory and replenishment plans to meet the product needs of our customers and patients, developing short and long-term inventory and assurance of supply strategies, scenario planning and risk mitigation plans, order management and execution of replenishment activities from AbbVie sources, distribution centers and third-party manufacturers, as well as communication with affiliates and other third-party customers on inventory and replenishment timing. Scenario planning collaboratively with key stakeholders is critical to business planning for launches, LOE and transfers. The team also manages significant cash flow. Responsibilities • Leadership to the US Medical Device & Aesthetics businesses Supply Planning team and accountable for supply planning activities to maintain required product availability for the patient and to meet strategic and financial needs of each brand while balancing IME/TPM plan requirements., • Drive resolution of elevated challenges around supply disruptions, capacity constraints, or other issues that may impact the availability of product for our customers and patients. Ensure proper communication of such challenges to senior leaders in Operations and the broader AbbVie organization., • Lead strategic programs that support enhancement of planning capabilities to meet the needs of the evolving organization. Influential in establishing business case for change with senior management, • Identify and evaluate continuous improvement opportunities to elevate performance of teams and seek organizational efficiencies. Sponsor projects within the team to implement such continuous improvement opportunities., • Develop and maintain effective relationships with key stakeholders including, but not limited to, Distribution & Logistics, Operations Brand Management, Demand Planning, Commercial, Quality, Internal Manufacturing & Engineering, External Supply and Finance., • Management oversight of the critical partnership between Supply Planning and manufacturing sites including external suppliers, accountable for the success of the joint planning processes., • Deliver short and long-term financial, customer service, and other performance goals of the Supply Chain organization., • Member of the Global Supply Planning leadership team supporting and assisting with global supply strategy development and deployment., • Motivate, coach, and develop managers and supervisors to becoming great people leaders. Drive the AbbVie culture across the team and create and sustain a positive environment displaying high levels of motivation and excellent team spirit. #LI-AL1 Qualifications • Bachelor or Master level in Operations, Supply Chain, Engineering, or Business Management required., • Master of Business Administration strongly preferred., • 10+ years of experience in Operations, including strong experience in Supply Chain and Manufacturing. Experience working in a Pharmaceutical manufacturing environment desired., • Pharmaceutical/Medical Devices experience required., • Excellent leadership and people management experience required., • Strategic mindset and ability to think at an enterprise level., • Strong communication skills and executive presence for interacting with senior leaders., • Ability to develop and maintain strategic relationships with stakeholders., • Proven success in leading effective teams and fostering collaboration across cultural and organizational boundaries., • Proven ability to manage, implement, and influence large change management programs. 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 Description Job Title : Regulatory Support Location: Basking Ridge NJ Remote Option: Yes. But the candidate should be available to attend customer meetings twice in a month Requirements Mandatory skills: -experience in pharmaceutical environment. -Experience in regulatory environment is required. -High level exposure or knowledge about FDA inspection and internal audit process. -Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc. Job Title: Consultant JD details : -Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance. -Represents Regulatory Affairs on cross-functional project teams. -Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents. -Work with subject matter experts, and cross functional departments to support business needs. -Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation. -Gather and assemble information necessary for submissions in accordance with regulations/guidance. -Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary. -Conduct review of published submissions to ensure consistency and compliance with regulatory requirements. -Maintain knowledge of local and global regulatory submission requirements. -Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives. -Provide Regulatory Affairs support during internal and external audits and inspections. -Exposure in Change management process, requirement gathering, qualifying the changes etc., -Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc. -Consistently support for regulatory systems access and change management. -Responsible for communicating business process improvements, business related issues, status updates or opportunities. Qualifications: -Bachelors’ degree, preferably in a life science or a related field -5 to 10 years of experience in pharmaceutical environment. -Experience in regulatory environment is required. -Excellent written, verbal communication and presentation skills. -High level exposure or knowledge about FDA inspection and internal audit process.

Job Description Source One Technical Solutions is seeking a Complaint Vigilance Analyst experienced in documenting and tracking corrective actions and complaint investigations in health care, pharmaceuticals, consumer care, medical devices, or related for an exciting opportunity with a global consumer product manufacturing company based in Summit, NJ. We are an equal opportunity employer, however there are no sponsorship or corp-to-corp contracts available. Please only apply if you can work on a W2 contract with no future sponsorship requirements. Thank you. Job Title: Complaint Vigilance Analyst II (Contractor) Hybrid: 2 days onsite and 3 days remotely $35.35 / W2 per hour The contract duration is initially 6 months, with a likely extension 40 hours/week, Mon-Fri Onsite Duties: • Processing product quality complaints and supporting day-to-day activities for complaint management for the North America region and globally., • Conduct initial assessment and identification of complaints in alignment with the product quality complaint program., • Review of complaints to verify customer verbatim, lot number, subject coding, and trend analysis., • Analyze complaint data for timely processing and investigation of complaints related to product quality issues., • Review and process updated information for complaint change logs from the call center and medical safety to assess impact on triage and investigation process., • Collaborate with cross-functional teams such as Global Consumer Care, Medical Safety Internal affiliates and External site representatives to address and resolve complaints efficiently., • Monitor complaint records in the complaint management system to ensure standard process is being followed and complaints are closed as required., • Prepare reports as requested in support of internal and external audits as needed., • Compiles product and lot-specific complaint trending data and complaint closure metrics as requested., • Assist with global and regional projects within the department, communicate effectively with all levels of management., • Assist with/participate in various projects and activities related to Complaint Vigilance process and system implementations and improvements. Support identification of continuous improvement activities., • As necessary, this position will support the Analyst functions in other Geographical regions for Consumer products. Required: • Detail-oriented with the ability to document and track corrective actions and complaint investigations, • Proficiency in the use of computer systems and applications such as Microsoft Office Suite, • Strong analytical skills with the ability to interpret complex data effectively, • Experience with data analysis and reporting tools, with a focus on identifying trends and insights, • Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams, • Ability to adapt to changing priorities and work effectively in a fast-paced environment, • Demonstrated ability to work as part of a team to achieve organizational goals, • Knowledge of regulatory requirements and quality assurance processes in the healthcare industry.Company DescriptionA WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.A WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.

Job Description At Truepill, we power the future of consumer healthcare. We started in 2016 with a vision to modernize healthcare. We provide the building blocks needed to launch and scale world-class healthcare experiences. With millions of prescriptions shipped and millions of patients served, we work with many of the world's largest healthcare organizations - including payers, providers, life sciences companies, consumer health brands, and government agencies. And with new partners continually joining our mission, we aim to further shape the future of healthcare - one patient at a time. Come join us. Let's build something great together. About the Role We're looking for an experienced Staff Pharmacist to support our Operations Management department. The Staff Pharmacist is an individual contributor reporting to the Pharmacist in Charge. As a Staff Pharmacist with Truepill, you will play a key role in managing Pharmacy Technicians and delivery personnel, ensuring the delivery of high-quality pharmaceutical services, and maintaining regulatory compliance. Why You'll Love Working at Truepill… • We put patients first – We put patients first because their well-being is our priority., • We are curious – We never settle for how it's done today. We invent how it will be done tomorrow. Because we don't just ask "why?", we ask "why not?"., • We have impact with urgency – We're the spark that ignites positive change in healthcare. We create impact because we don't anticipate; we innovate., • We lead with Integrity – Leading with integrity is the foundation of trust. We always do what's best for our people, our customers, and above all, our patients., • We hold customer confidentiality – We put discretion & confidentiality at the heart of every relationship. You're excited about this opportunity because… • You will help with oversight of all Pharmacy Technicians and delivery personnel., • You will maintain appropriate documentation for services rendered, including prescription records and patient profiles., • You'll coordinate the provision of pharmaceutical services and the delivery of medications and products to patients., • You will ensure the security of legend drugs and adherence to regulatory standards., • You will participate in the quality assurance program to maintain and improve pharmacy operations., • You will maintain patient confidentiality with medication profiles and sensitive information., • You'll collaborate with cross-functional teams to support organizational goals and initiatives., • Your daily duties will include patient consultations, prescription verification, and drug utilization reviewWe're excited about you because…, • You have an active, clear, and unrestricted Pharmacist license within the state of residence., • You are a Registered Pharmacist in good standing with the Board of Pharmacy., • You have a Bachelor's degree in Pharmacy or Pharm D degree., • You possess a minimum of 1 year of pharmacy experience, preferably in a clinical setting., • You have the ability and willingness to work at a computer screen for long periods if needed., • You have demonstrated excellent leadership and organizational skills to effectively manage pharmacy operations., • You display a commitment to patient-centered care and adherence to ethical standards. Diversity, Equity, Inclusion & Belonging Truepill is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Job DescriptionJob Title: Aseptic Technician - 2nd ShiftJob Description Join a dynamic team dedicated to transforming the treatment of bladder cancer. As an Aseptic Technician, you will play a crucial role in ensuring the quality and integrity of our manufacturing processes. You will work collaboratively with cross-functional teams to validate new areas, troubleshoot issues, and contribute to continuous improvement initiatives. Responsibilities • Assist with the validation of new areas, including manufacturing equipment and processes., • Collaborate with Quality Assurance, Quality Control, and Maintenance teams to troubleshoot issues and resolve deviations., • Participate in aseptic process simulations, media fills, and equipment qualifications., • Conduct in-process inspections and quality control checks to verify product quality., • Complete necessary logbook, form, and batch record documentation while adhering to cGMP and Good Documentation Practices., • Contribute to process enhancements, waste reduction, and efficiency improvements., • Complete initial aseptic gowning and process qualification and maintain qualification for Grade A and B environments., • Ensure compliance with policies, guidelines, and regulatory requirements., • Experience in aseptic clean rooms (Grade A & B) and filling rooms., • 2-3 years of industry experience., • Proficiency in aseptic techniques, troubleshooting, and manufacturing processes., • Familiarity with cGMP and cleanroom protocols., • Ability to read and comprehend work instructions and standard operating procedures., • Strong attention to detail, accuracy, and documentation skills., • High school diploma or equivalent; technical or vocational education is a plus., • Minimum 1 year experience in the pharmaceutical/biopharma/biotech industry., • Ability to understand equipment alarms and escalate as necessary. Work in a Grade A & B clean room environment where aseptic gowning is crucial. The role requires flexibility in working shifts, which may include evenings, nights, weekends, and holidays, as per production schedules. Job Type & Location This is a Contract to Hire position based out of Parsippany, New Jersey. Pay and Benefits The pay range for this position is $28.00 - $28.84/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Parsippany,NJ. Application Deadline This position is anticipated to close on Sep 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description Johnson Service Group is an award-winning staffing company that is looking for a Bioanalytical Scientist with 3-7 years’ experience. This is a contract opportunity with a large pharmaceutical company in Rahway, NJ. Salary: $50/hr Schedule: M-F 8:00 a.m. – 5:00 p.m. Seeking a motivated individual to work as a senior bioanalytical bench scientist within its Good Laboratory Practices (GLP) bioanalytical laboratory. This is a bioanalytical senior scientist position with primary duties in performing laboratory work, preparing reports, and interacting with internal and external partners. This position is a part of the Bioanalytical group, Global Preclinical Development, based in Rahway, New Jersey. Key Responsibilities: · Independently developing, optimizing and troubleshooting LBA methods to support projects with method quality and efficiency in mind; writing bioanalytical methods; assumption of project responsibility in delegated bioanalytical aspects. · Proficiently and independently implementing ligand binding assays (LBA) for the analysis of biological samples in a GLP environment, with duties inclusive of, but not limited to, sample preparation, setting up instruments, processing, and interpreting data; solving issues encountered during method implementation independently. · Establishing LBA capability within the team including equipment purchasing, setting up lab and LBA workflow. · Ensuring that all documentations are in real time, accurate and compliant with current GLP and departmental guidelines. · Preparing reports (sample analysis and validation) independently; Assembling all documents for regulatory submissions; Compliance with and maintenance of required training for company and departmental SOPs, safety-related guidance and other guidelines as relevant/applicable. · Adherence to short term goals, objectives and timelines agreed upon with management, via working independently (e.g., with little to no management oversite in this regard). · Interaction with partners in other functional lines, such as Drug Safety and Metabolism, Quality Assurance, and program management. · Any relevant/applicable additional BA assignments as directed by management. · Ability to multi-task and be a team player. Qualifications: Education: · Ph.D. degree in chemistry, biochemistry or related scientific discipline with 3 years of industry experience · Master of Science degree in chemistry, biochemistry or related scientific discipline with 7 years of industry experience Experience: · Experience in developing, validating and implementing ligand binding assays under GLP. · Possess excellent written and verbal communication skills. · Experience in Watson or other LIMS systems. · Proficiency with Microsoft Office products. • Highly motivated individual with the aspiration to learn and develop himself/herself., • Experience in LC-MS/MS assay. Company DescriptionOur people and culture make JSG a great place to work. JSG’s mission is to empower people, help our clients reach their goals, and hire motivated individuals. Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with 40 years of experience investing in people and companies. We are always looking for great people to join our team—we want to see your success here at JSG! We can be found locally in more than 30 offices throughout the United States and Canada. JSG continues to work diligently to offer our clients and candidates world-class service and diversified offerings to fit their evolving needs. We offer medical, dental, vision, life insurance options, 401(k), weekly pay, and more. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.Our people and culture make JSG a great place to work. JSG’s mission is to empower people, help our clients reach their goals, and hire motivated individuals.\r\n\r\nJohnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with 40 years of experience investing in people and companies. We are always looking for great people to join our team—we want to see your success here at JSG! We can be found locally in more than 30 offices throughout the United States and Canada. JSG continues to work diligently to offer our clients and candidates world-class service and diversified offerings to fit their evolving needs.\r\n\r\nWe offer medical, dental, vision, life insurance options, 401(k), weekly pay, and more.\r\n\r\nJohnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)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 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 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 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 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 Description Overview Are you looking for a career you can feel good about? We hire only those that strive to do their best. By joining our family, you'll receive the honor and recognition that comes with working for the industry's global leader in evidenced based rehabilitation. Who We Are: GEO provides complementary, turnkey solutions for numerous government partners worldwide across a spectrum of diversified correctional and community reentry services. From the development of state-of-the-art facilities and the provision of management services and evidence-based rehabilitation to the post-release reintegration and supervision of individuals in the community, GEO offers fully diversified, cost-effective services that deliver enhanced quality and improved outcomes. Why Work for GEO: • We believe that work is more than a place you go to every day. It is about being inspired and motivated to achieve extraordinary things., • Employee benefits play an important role in making The GEO Group a great place to work. At GEO, we believe in the three pillars of employee wellbeing: physical, emotional, and financial. With comprehensive benefits and competitive wages, we trust that you will find all the resources you need here to be successful. Responsibilities Summary: The Physician is the first point of contact for many detainees/inmates and as a result must be able to diagnose a wide range of illnesses and injuries. The primary care/internal medicine Physician is also responsible for managing the overall care of the patient and communicating with the specialist or specialists as needed. The Physician manages and evaluates the medical program activities based on industry standards and contractual obligations. This position also functions as liaison between correctional officials, public agencies, and the company. Implements all contractually required services. Primary Duties and Responsibilities: • The Physician examines and treats to ensure proper injury care, disease prevention, diagnosis, treatment and recovery on detainees/inmates referred by the nursing/professional staff under established clinical practice guidelines., • The Physician provides medical treatment and orders studies, tests and ancillary services required consistent with the provision of basic health care services., • Prescribes pharmaceuticals, other medications, and treatment regimens to treat identified and documented medical conditions and regularly reviews those cases requiring ongoing medical/pharmaceutical attention to include the administration and education of appropriate use of vaccines., • The Physician discusses potential side effects of medication/treatment with patients and ensure that all allergy information is up to date before prescribing medication/treatment., • Provides advice to patients for lifestyle and diet changes that may improve their health or help to treat the health issue they are experiencing., • The Physician produces clear and concise health records, reports and correspondence, including the use of Electronic Health Records system., • Maintains patient confidentiality and comply with all federal and state health information privacy laws., • The Physician collaborates and communicates effectively with the Hospital medical team, Psychiatric, Mental Health Professionals, Nurses, Health Technicians and Administrative Assistants., • The Physician maintains professional and technical knowledge by attending educational workshops/seminars/conferences, reviewing professional publications, establishing personal networks, and participating in professional societies, and completes required Continuing Medical Education requirements., • Maintains a professional appearance and demeanor., • The Physician provides 24-hour on-call coverage to advise nursing staff in the care of detainees., • Performs regular chart review for quality assurance purposes and countersigns telephone orders., • The Physician designates the level of care to be performed, and the necessary equipment needed. Identifies continuing care facilities and specialty physicians., • Initiates dental and psychiatric referrals., • The Physician participates in Mortality Reviews., • Reviews and responds to your Peer Reviews., • The Physician performs other various duties as assigned. Qualifications Minimum Requirements • Medical degree in medicine from an accredited school and licensed to practice as a medical or osteopathic physician in the state in which the facility is located required. Board Certified/Board Eligible in primary care or related field preferred., • Two (2) years of direct work experience as a Physician., • Completion of a U.S. -based residency program required., • Current DEA and D.P.S. Certificate of Registration., • Professional license must remain on file at all times at the facility where services are located., • Ability to provide independent, critical thinking skills necessary to aid all medical provider roles serving detainees and collaborate effectively with subspecialist consultants., • Understand and possess up-to-date pharmacology, safety, and medical skills necessary to teach and perform the medical provider/director role., • Must be able to deal effectively with difficult detainees and facility staff at times., • Must be comfortable utilizing Electronic Health Record systems, training will be provided., • Demonstrate the ability to adjust medical techniques to accommodate the needs of the specialized population of the detention setting. This includes communication between medical staff and detention staff about the care of detainees while understanding and adjusting for the unique security issues of the facility.

Job Description Position: Senior Validation Project Lead - Aseptic Liquid Fill Critical Utilities Location: Midwest US (Traveling) Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry. We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today’s world, it’s never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services. Compli is full services Commissioning, Qualification, Regulatory Compliance and On Demand services firm. Supervisory Responsibilities: * None Essential Functions: • Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects., • Prepare and execute commissioning / validation lifecycle documents., • Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade., • Write summary reports for validation and qualification protocols., • Support project milestones, priorities and deadlines., • Write operating procedures for technical equipment and practices and procedures., • Perform system and process risk assessments and analyses., • Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management., • Develop project specific validation plans and strategy., • Able to manage and execute multiple projects to meet client’s priorities., • Provide a practical approach to problem solving., • Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers., • Bachelor's degree in a related life sciences or requisite industry training and experience., • Ability to converse about scientific matters., • Ability to work independently or in collaboration with others., • In depth understanding and application of validation principles, concepts, practices and standards., • Considered a Subject Matter Expert (SME) in one area of validation., • Proficient in current Good Manufacturing Practices and other applicable regulations., • Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report., • Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards., • Excellent written communication skills with emphasis in technical writing., • Prolonged periods of sitting at a desk and working on a computer. At Compli, we are about innovative and intelligent people who want to solve problems. We’re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology. At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.

Job Description Position: Senior Validation Project Lead - Medical Devices, Life Sciences Group Location: Midwest US (Traveling) Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry. We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today’s world, it’s never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services. Compli is full services Commissioning, Qualification, Regulatory Compliance and On Demand services firm. Supervisory Responsibilities: * None Essential Functions: • Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects., • Prepare and execute commissioning / validation lifecycle documents., • Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade., • Write summary reports for validation and qualification protocols., • Support project milestones, priorities and deadlines., • Provide project reporting (budgets, status and scheduling reports), • Write operating procedures for technical equipment and practices and procedures., • Perform system and process risk assessments and analyses., • Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management., • Develop project specific validation plans and strategy., • Able to manage and execute multiple projects to meet client’s priorities., • Provide a practical approach to problem solving., • Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers., • Bachelor's degree in a related life sciences or requisite industry training and experience., • Ability to converse about scientific matters., • Ability to work independently or in collaboration with others., • In depth understanding and application of validation principles, concepts, practices and standards., • Considered a Subject Matter Expert (SME) in one area of validation., • Proficient in current Good Manufacturing Practices and other applicable regulations., • Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report., • Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards., • Excellent written communication skills with emphasis in technical writing., • Prolonged periods of sitting at a desk and working on a computer. At Compli, we are about innovative and intelligent people who want to solve problems. We’re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology. At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.

Job Description Job Description One of the nation’s largest independent testing facilities seeks a Stability and Study Coordinator with a minimum of 2 years stability systems experience in a GMP environment. The perfect candidate will also have previous experience as an Analytical Chemist with a minimum 2 years experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Must have the technical ability to understand client requirements, technical documentation, and be able to prepare testing protocols. Responsibilities include, but are not limited to the following: • Communicates with clients regarding studies to ensure timely processing and submission to the laboratories., • Entry of stability studies and all associated information into company software system and communicates the stability testing schedules to department management., • Performs time point pulls within the acceptable guidelines and documents details as per SOPs, customer and regulatory requirements., • Submission of the stability samples to the appropriate departments., • Develops and generates stability study protocols according to customer requirements and timelines, internal SOPs and regulatory requirements., • Compilation of time point raw data and verification of results entry into stability system as well as generation of interim and summary time point data and reports., • Prepares the generation of shelf life summary reports for products based on compiled data., • Coordinates with department management regarding stability workload and schedules to ensure timelines are met., • Preparation of sample shipments and paperwork for returned samples., • Entry of routine, development and validation studies and all associated information into company software system and communicates the study details to department management., • Documents work clearly and accurately., • Perform technical writing and peer review as needed, • Capable of working in a fast paced environment. Education and Experience • Bachelor's degree in chemistry or other related degree, preferred., • Minimum 2 years of stability systems experience in a GMP laboratory., • Minimum 2 years of product testing experience in a GMP laboratory., • ISO 17025 experience a plus., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Ability to stand/sit in office and laboratory environment., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Vision accuracy and color detection are required for this position, • Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc., • Ability to lift up to 30 lbs. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law. Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Job Description One of the nation’s largest independent testing facilities seeks an Analytical Chemist with a minimum 2 years' experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Responsible for performing physical, chemical and instrumental techniques on APIs, raw materials and finished products according to schedule. Must have the technical ability to understand client requirements and assist in the preparation of testing protocols. • Run instrumentation such as, but not limited to: ICP-MS, HPLC, GC,UV, IR, AA, DSC, KF on products according to compendial, client and internal methodologies., • Prepare standards and samples for analysis., • Perform physical, chemical and instrumental techniques on APIs, raw materials and finished products., • Execute method transfer and validation protocols., • Document work clearly and accurately., • Perform technical writing and peer review as needed., • Operates and maintains laboratory equipment and instrumentation required for cGMP analysis of samples., • Bachelor's degree in chemistry or other related degree, preferred., • Minimum 2 years of product testing experience in a GMP laboratory., • ICP-MS/OES experience required., • Previous data acquisition software (Totalchrome, Empower, etc.) experience required., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Ability to stand/sit in office and laboratory environment., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Vision accuracy and color detection are required for this position, • Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc., • Ability to lift up to 30 lbs.Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Prior experience (10 years minimum) in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality Systems and regulatory requirements. Provide calibrated Quality oversight based on product type, capa

Job DescriptionJob Title: QA InvestigatorJob Description We are seeking a dedicated QA Investigator to join our team. The role involves writing and completing investigations and deviations, ensuring compliance from both compliance and operations perspectives. The ideal candidate will conduct root cause analysis and manage the entire lifecycle of investigations independently, communicating effectively with vendors and manufacturing teams. Responsibilities • Determine the causes and preventative actions of Deviations, Non-Conformances, Out of Specification (OOS), Out of Trend (OOT), field complaints, and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools and 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 to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track Corrective and Preventive Action (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 approaches., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy, and deviation processes., • Champion CAPA plans and implementation., • Provide communication plans for ongoing deviations and CAPAs., • Create and communicate CAPA plans effectively to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • 2-3 years of experience writing and reviewing deviations and investigations., • Experience within a pharma company supporting manufacturing., • Previous experience within a quality assurance team., • Bachelors degree within a related scientific field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operations., • Experience using e-Quality Management Systems., • Experience with CAPA and GMP., • Knowledge of biopharma/biotech and biologics., • Technical writing skills. The QA Investigator will work closely with quality assurance and a team of QA/QC professionals on a daily basis, collaborating cross-functionally with the manufacturing team. The role is based at two sites located a block apart, and the team currently includes five other investigators. The position operates on a first-shift schedule from Monday through Friday, with start times at either 8 am or 9 am. The company offers a supportive work culture with opportunities for growth and expansion, focused on saving patients' lives. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. Pay and Benefits The pay range for this position is $40.00 - $46.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Sep 19, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job DescriptionJob Title: Technical Writer Compliance Job Description We are seeking a Technical Writer Compliance expert to manage and complete investigations and deviations from a compliance and operations perspective. The role involves technical writing, conducting root cause analysis, and collaborating with cross-functional teams to ensure GMP compliance and effective communication with vendors and manufacturing personnel. Responsibilities • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints, and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools and benchmark industry standards., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to 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 approaches., • Develop materials to train and educate personnel on writing problem statements and root cause analysis tools., • Champion CAPA plans and implementation., • Provide communication plans for ongoing deviations and CAPAs., • Effectively communicate CAPA plans to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • 3-5 years of experience writing and reviewing deviations and investigations., • 3-5 years of experience within a pharmaceutical company supporting manufacturing., • Experience within a quality assurance team., • Proficiency in technical writing and root cause analysis., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma., • Bachelor's degree in a related scientific field., • Experience with cell and gene or biologics., • Experience using e-Quality Management Systems preferred., • Relevant IT skills, including proficiency with Visio, Microsoft Project, and Excel. Join a growing company with a positive work culture dedicated to saving patients' lives. The role offers exposure to new technical writing techniques and the opportunity to work with cross-functional departments daily. The company is expanding, providing ample opportunities for internal growth and development. Pay and Benefits The pay range for this position is $50.00 - $55.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Parsippany,NJ. Application Deadline This position is anticipated to close on Sep 22, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description Overview Prepares technical and clerical tasks associated with the preparation, labeling and dispensing of pharmaceuticals. Plays an integral role in the inventory and quality assurance activities. Schedule: Monday - Friday 9:00am - 5:30pm • Competitive Pay, • Health, Dental, Vision & Life Insurance, • Company-Paid Short & Long-Term Disability, • Flexible Schedules & Paid Time Off, • Tuition Reimbursement, • Employee Discount Program & DailyPay, • 401k, • Pet Insurance Responsibilities • Coordinates and facilitates new referrals and admissions through collaboration with nurses, customer service and distribution, • Conducts and documents initial and ongoing assessment of specific patient, drug and disease information to identify real and potential drug-related problems or needs, • Escalates to a clinician as needed, • Answers inquiries from patients, families, physicians and other healthcare professionals. Escalates to a clinician as needed, • Maintains thorough and appropriate documentation in the customer/patient record of all clinical activities and communication with patients, physicians and other healthcare professionals, • Coordinates and schedules the preparation of IV therapies and home medical equipment orders with the assistance of the Pharmacist, • Helps coordinate patient care activities with Pharmacists, Nurses, other Technicians and Patient Care Coordinators, • Prepares labels, prescriptions and compounding/mixing worksheets and completes and maintains product lot numbers, expiration dates and batch records, • Generates delivery/pick slips under the supervision of the Pharmacist. Picks and pulls supplies and home medical equipment, • Obtains supply inventories from patients/clients and communicates information obtained to the Pharmacist as required and documents all communication in patient progress notes on the pharmacy computer system, • Participates in branch management, department and intra-departmental meetings and quality improvement activities, • Adheres to all accreditation, OSHA, FDA, state, local and federal regulations and standards relevant to infusion pharmacy and home medical equipment, • Other duties as assigned, • Supervisory Responsibility: No Qualifications • Successful completion of an approved/accredited pharmacy technician training program; IV certification preferred, • Registered Pharmacy Technician license in state of practice per state regulations, • National Pharmacy Technician Certification as required by the state board of pharmacy in state of practice, • One to three (1-3) years of related pharmacy experience in a home care setting, retail, or pharmacy setting, • General knowledge of drug terminology, pharmaceutical calculations, drug use and aseptic techniques, • Flexible schedule with the ability to work on-call evenings and weekends on an as-scheduled basis, • Effective mathematical and communication skills required, • Basic pharmacy knowledge of reading and interpreting prescriptions, • Ability to work independently, accurately, and efficiently, • Valid driver’s license, preferred Driving Position: Yes To perform this role will require constant sitting and typing on a keyboard with fingers, and occasional standing, and walking. The physical requirements will be the ability to push/pull and lift/carry 10-30 lbs

Job Description SUMMARY: • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files, • Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications., • Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements., • Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data., • Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing. Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field. Experience: • Prior experience in pharmaceutical or regulatory writing., • CMC (Chemistry, Manufacturing, and Controls) Writer experience.

Job Description CMC Writer, Chemistry, Manufacturing, and Controls, Regulatory, Drug Development, Manufacturing, and Quality Control, NDA/MAA CTD, EU (IMPD and MAA), US-FDA, FDA, If you post this job on a job board, please do not use company name or salary. Experience level: Mid-senior Education level: Bachelors degree Job function: Health Care Provider Industry: Pharmaceuticals Pay rate : Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No SUMMARY: • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files, • Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications., • Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements., • Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data., • Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing. Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field. Experience: • Prior experience in pharmaceutical or regulatory writing., • CMC (Chemistry, Manufacturing, and Controls) Writer experience.

Job Description Overview Prepares technical and clerical tasks associated with the preparation, labeling and dispensing of pharmaceuticals. Plays an integral role in the inventory and quality assurance activities. Schedule: Monday - Friday 9:00am - 5:30pm • Competitive Pay, • Health, Dental, Vision & Life Insurance, • Company-Paid Short & Long-Term Disability, • Flexible Schedules & Paid Time Off, • Tuition Reimbursement, • Employee Discount Program & DailyPay, • 401k, • Pet Insurance Responsibilities • Coordinates and facilitates new referrals and admissions through collaboration with nurses, customer service and distribution, • Conducts and documents initial and ongoing assessment of specific patient, drug and disease information to identify real and potential drug-related problems or needs, • Escalates to a clinician as needed, • Answers inquiries from patients, families, physicians and other healthcare professionals. Escalates to a clinician as needed, • Maintains thorough and appropriate documentation in the customer/patient record of all clinical activities and communication with patients, physicians and other healthcare professionals, • Coordinates and schedules the preparation of IV therapies and home medical equipment orders with the assistance of the Pharmacist, • Helps coordinate patient care activities with Pharmacists, Nurses, other Technicians and Patient Care Coordinators, • Prepares labels, prescriptions and compounding/mixing worksheets and completes and maintains product lot numbers, expiration dates and batch records, • Generates delivery/pick slips under the supervision of the Pharmacist. Picks and pulls supplies and home medical equipment, • Obtains supply inventories from patients/clients and communicates information obtained to the Pharmacist as required and documents all communication in patient progress notes on the pharmacy computer system, • Participates in branch management, department and intra-departmental meetings and quality improvement activities, • Adheres to all accreditation, OSHA, FDA, state, local and federal regulations and standards relevant to infusion pharmacy and home medical equipment, • Other duties as assigned, • Supervisory Responsibility: No Qualifications • Successful completion of an approved/accredited pharmacy technician training program; IV certification preferred, • Registered Pharmacy Technician license in state of practice per state regulations, • National Pharmacy Technician Certification as required by the state board of pharmacy in state of practice, • One to three (1-3) years of related pharmacy experience in a home care setting, retail, or pharmacy setting, • General knowledge of drug terminology, pharmaceutical calculations, drug use and aseptic techniques, • Flexible schedule with the ability to work on-call evenings and weekends on an as-scheduled basis, • Effective mathematical and communication skills required, • Basic pharmacy knowledge of reading and interpreting prescriptions, • Ability to work independently, accurately, and efficiently, • Valid driver’s license, preferred Driving Position: Yes To perform this role will require constant sitting and typing on a keyboard with fingers, and occasional standing, and walking. The physical requirements will be the ability to push/pull and lift/carry 10-30 lbs