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If you are a current Jazz employee please apply via the Internal Career site. \n Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to \ntransform the lives of patients and their families. We are dedicated to developing \nlife-changing medicines for people with serious diseases — often with limited or no \ntherapeutic options. We have a diverse portfolio of marketed medicines, including leading \ntherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. \nOur patient-focused and science-driven approach powers pioneering research and development \nadvancements across our robust pipeline of innovative therapeutics in oncology and \nneuroscience. Jazz is headquartered in Dublin, Ireland with research and development \nlaboratories, manufacturing facilities and employees in multiple countries committed to \nserving patients worldwide. Please visit\nwww.jazzpharmaceuticals.com\nfor more information. \n The Senior Oncology Account Manager is responsible for direct promotion of Jazz Pharmaceuticals’ products, and the development and management of business relationships with therapeutic specialists within an assigned geographical territory. The Senior Oncology Account Manager (OAM) is an integral part of the commercial team that includes all personnel dedicated to the sales and marketing functions. The Senior Oncology Account Manager will implement Jazz Pharmaceuticals’ marketing strategies and marketing tactics to achieve sales goals through short-term and long-term objectives. The current disease areas of focus: Small Cell Lung Cancer (SCLC) and Gastrointestinal (GI) Cancers. This position reports directly to the Regional Sales Manager. Key Skills: Strategic Account Management: Customer Understanding Possess strong sales analytics capabilities with demonstrated understanding of prescribing and purchasing decision processes and any marked differences from national trends Demonstrate a thorough understanding of: Internal customer business models - how profit is generated, business and financial risks, cost impacts of managing patient care External customers - current reimbursement landscape/managed care, payer issues and trends, and other factors which inform the development of one’s annual territory business plan Gain understanding of customer needs through thorough research and analysis to understand the specific needs and requirement of each customer and/or account Identify key stakeholders within the account and understand their roles, priorities, motivations and patient needs Proven excellence to leverage all available resources - dashboards, alerts, omnichannel reports, speaker programs, conference attendance Actively gain customer insights and provide timely feedback to cross-functional partners and regional sales manager regarding account business trends, changes in the therapeutic landscape, performance, industry issues and business opportunities and obstacles Strategic Planning: Keep the needs and expectations of the customer/patients at the forefront of all that we do Define clear, measurable objectives that align both with the company goals and the goals and needs of the customer Develop tailored strategies and tactics to address the unique needs and challenges of each customer Determine the resources required to execute the strategic account plan effectively Continuously review and adjust the strategic account plan based on activities, feedback, changing market conditions and evolving customer needs Develop and implement customized account strategic plans with clear next steps, specific strategies and tactics and appropriate utilization of resources while meeting the needs of our customers Demonstrated collaborative efforts with cross-functional teams including marketing, medical affairs and market access to align and execute on account strategies to achieve common business objectives Work with customer facing colleagues to facilitate achievement of the respective functional tactical objectives Recognize changes in the work environment to ensure effective development and implementation of alternate plans to achieve objectives, modify call plan/business plan activities as needed Strong ability to identify patterns and trends from multi-source data (OmniChannel) for divergent collaborative problem solving Teamwork & Collaboration: Maintain an enterprise mindset and cross-functional thinking to maximize one Jazz customer engagement Highly effective at leveraging cross-functional partnerships with marketing, medical affairs and market access with the goal to advance Business Unit and organizational interests Engage and align with cross-functional partners to mobilize resources and ideas to deliver to successfully meet customer and patient needs Actively shares insights and best practices across the team; demonstrates trust in others by consistently finding opportunities to contribute to their effectiveness and impact Work effectively with customer facing colleagues to facilitate achievement of the respective functional teams tactical objectives Lead where appropriate as the main point of contact for designated accounts and collaborate with cross-functional partners to create a streamlined, organized interface between account stakeholders and all field facing colleagues Selling Effectiveness: Effective promotion of Jazz Pharmaceuticals Adult Oncology products to physicians and other health care providers within the designated area at both community and Academic centers Institute a network-selling mindset to customer relationships, seeing them as part of a connected healthcare ecosystem to broaden connections across an account Stay abreast of industry trends, competitive landscape, and clinical developments in oncology to effectively communicate product differentiation and value proposition Ability to adapt quickly to new tools and resources for successful customer engagement; leverages analytics to assist with developing insights and next best action plans Identify, establish and maintain strong relationships with key physicians, health care providers and organizations within assigned territory Product and Scientific Knowledge: Educate physicians and other health care professionals about Jazz Pharmaceuticals product(s), providing the most current information about the approved indications for the company’s products within the current disease areas of focus: Small Cell Lung Cancer (SCLC) and Gastrointestinal (GI) Cancers Demonstrates a superior level of effectiveness in communicating, educating, and consulting across multiple disease states Effectively and appropriately responds to the customer’s questions about other approved products/therapies, based on the clinical information contained in the package insert and per company compliance guidelines Demonstrate to customers and internal team members a high level of clinical knowledge of: the disease state Jazz product(s), based on the clinical information contained in the package insert Demonstrates confidence in appropriately challenging prescribers about treatment decisions associated with assigned product Execution: Participate in organizing and facilitating meetings for the exchange of medical and product information in line with the company’s policies, regulatory and legal requirements Represent company at live and virtual conferences, attend company meetings, educational events, training programs and functions as needed Utilize CRM tools to effectively manage customer interactions, track sales activities and maintain accurate territory records Present a positive and professional image of Jazz Pharmaceuticals, and ensure activities are consistent with and enhance the company’s ethical pharmaceutical marketing policies and procedures Special projects as assigned Comply with all legal/regulatory guidelines of the Food, Drug and Cosmetic Act, the Prescription Drug Marketing Act, the Pharma Code, OIG guidelines, and all other applicable federal and state regulations Perform all activities within allocated budget Required Experience: Four-year college/university degree Experience in Oncology Excellent verbal and written communication skills with an effective presentation style both in face to face and virtual interactions to connect and build credibility with healthcare professionals Ability to meet territorial travel requirements Preferred Experience: Post-graduate business school study, training Minimum of 5 years in the oncology market Strong clinical, technical and scientific knowledge of product(s); applicable disease states desired Strategic thinker who can drive a strategic account business plan Strong key account management experience working in complex academic and community accounts, identifying influential stakeholders, and working with them to better serve patients Demonstrated history of strong business acumen, problem solving, effective prioritization, account management and effective sales data analytics skills Skillful in fostering teamwork and collaboration in cross-functional account management Results oriented with a proactive and self-motivated approach to driving sales growth Experience with GI, HER2 landscape, biomarker driven therapeutics and/or Lung Cancer highly preferred Key Account & Market dynamics knowledge Description of Physical Demands: Frequent travel between meeting sites Frequently operating a computer, printer, telephone and other similar office machinery Frequent interactions with external contacts in their office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes Frequent computer laptop or tablet use, not usually at a workstation Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands Frequent public contact requiring appropriate business apparel #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $155,200.00 - $232,800.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.

Job Description 2nd shift 1:30pm – 9:45pm Position Summary Our client is seeking a dependable and detail-oriented Material Handler to support warehouse and production operations at our Teterboro facility. This position is responsible for receiving, storing, staging, and transporting raw materials and finished goods while ensuring inventory accuracy, safety, and compliance with Good Manufacturing Practices (GMP) and company quality standards. The ideal candidate thrives in a fast-paced manufacturing environment and is committed to maintaining an organized and efficient warehouse operation. Essential Responsibilities • Receive incoming raw materials, packaging components, and production supplies., • Verify shipments against purchase orders and packing slips for accuracy., • Safely unload, inspect, label, and store materials in designated warehouse locations., • Pick, stage, and deliver materials to production departments according to manufacturing schedules., • Operate forklifts, pallet jacks, and other material handling equipment safely and efficiently., • Perform inventory transactions and maintain accurate inventory records within the ERP/WMS system., • Conduct cycle counts and assist with physical inventory activities., • Ensure proper stock rotation using FIFO (First-In, First-Out) inventory practices., • Maintain warehouse organization, cleanliness, and compliance with GMP, FDA, OSHA, and food safety standards., • Identify damaged, expired, or non-conforming materials and report discrepancies promptly., • Assist with packaging, labeling, and shipment preparation of finished products., • Support continuous improvement initiatives to enhance warehouse efficiency and inventory accuracy., • Follow all company safety procedures and wear required personal protective equipment (PPE). Qualifications • High school diploma or GED required., • 2+ years of warehouse, material handling, shipping/receiving, or manufacturing experience preferred., • Forklift certification or prior forklift operating experience strongly preferred., • Experience working in food, flavor, fragrance, pharmaceutical, chemical, or manufacturing environments is a plus., • Familiarity with inventory control systems, ERP software, or warehouse management systems., • Ability to read and understand shipping documents, inventory reports, and production paperwork., • Strong attention to detail and organizational skills., • Ability to work independently and as part of a team. Physical Requirements • Ability to lift, move, push, and pull up to 50 pounds regularly., • Ability to stand, walk, bend, reach, and perform repetitive movements throughout the shift., • Comfortable working in warehouse and manufacturing environments. Preferred Skills • Shipping and receiving experience., • Inventory control and cycle counting., • GMP and food safety knowledge., • Forklift and pallet jack operation., • Strong communication and teamwork skills., • Basic computer proficiency, including Microsoft Office and ERP systems. Our client offers a collaborative manufacturing environment where employees play a critical role in ensuring the timely flow of materials that support the production of world-class flavors, fragrances, and specialty ingredients.

Director of Maintenance – Bakery Manufacturing Role Summary The Director of Maintenance is responsible for providing strategic and hands-on leadership for all maintenance, reliability, and automation operations within the bakery facility. This role ensures the safe, reliable, and efficient operation of production equipment, utilities, and automated systems supporting 24/7 manufacturing. Success is demonstrated through measurable improvements in equipment reliability, repair efficiency, cost control, and safety. This role also develops and implements structured training programs to strengthen technician skills in troubleshooting, automation, controls, and reliability best practices. The Director of Maintenance leads preventive and predictive maintenance programs, manages breakdown response, oversees maintenance systems and inventory, and supports capital projects, construction, and equipment installations. This position requires strong technical expertise, disciplined leadership, and a proactive reliability mindset. Key Priorities · Drive equipment reliability and up time across all production and utility systems. · Establish a world-class preventive and predictive maintenance culture. · Lead maintenance teams with a strong focus on safety, accountability, and continuous improvement. · Support long-term automation and plant growth strategies. · Ensure compliance with food safety, electrical safety, and machine safety standards. Primary Responsibilities Maintenance & Reliability Leadership · Plan, manage, and continuously improve the preventive maintenance program to maximize equipment reliability and minimize downtime. · Direct and coordinate all corrective maintenance activities across production and facility systems. · Establish and lead structured root cause analysis (RCA) processes to eliminate repeat failures. · Develop, track, and analyze maintenance KPIs related to downtime, MTTR, MTBF, and PM effectiveness. Technical & Equipment Oversight · Provide technical leadership for bakery production equipment. · Ensure proper operation, maintenance, and reliability of compressed air, steam, water, and other critical utilities. · Oversee maintenance and performance of robotic systems and automated production lines, including pick-and-place robots, automated packaging, and material handling systems. · Develop and coordinate preventive and predictive maintenance strategies for the entire facility, reducing unplanned downtime and extending equipment life. · Coordinate preventive and predictive maintenance programs for all equipment. Projects & Capital Execution · Plan and manage construction-related maintenance projects, facility upgrades, and equipment installations. · Coordinate with engineering, contractors, and vendors to ensure projects are completed safely, on schedule, and within budget. · Support commissioning, start-up, and validation of new equipment and production lines. People Leadership & Development · Lead, mentor, and develop maintenance leadership and technician teams. · Lead training and skill development initiatives for maintenance technicians across all production and facility equipment systems. · Foster a culture of ownership, accountability, and continuous learning within the maintenance organization. · Partner cross-functionally with Operations, Engineering and Quality Teams. Qualifications Required · Bachelor’s degree in Electrical Engineering and/or Mechanical Engineering. · Minimum 10–15 years of maintenance experience in food manufacturing (preferred), pharmaceutical, or industrial manufacturing environments. · Minimum 5–7 years in a maintenance leadership or management role. · Strong technical knowledge of bakery or food manufacturing equipment and utilities. · Proven track record of implementing and improving maintenance and reliability practices. · Demonstrated leadership skills with the ability to lead teams in fast-paced, 24/7 manufacturing environments. · Strong communication, organizational, and problem-solving skills. · High work ethic, flexibility, and ability to multitask effectively.

Suanfarma is a life science company committed to health and progress. We specialize in the development, manufacturing, and distribution of high-quality active pharmaceutical ingredients—essential components of medicines that improve the lives of millions of people and animals worldwide. We are currently looking for a motivated professional to join our team. Duties: • Support and accompany the KAM in their commercial activities including customer visits and meeting preparation, • Summarize and monitor action items following customer meetings., • Coordinate internally to meet customer deadlines and response time, • Utilize and keep SalesForce updated to ensure timely customer management and follow up, • Process KAM’s POs and ensure correct handover to operations, • Strategically increase our win rate turning tail accounts into rising stars, • Prepare, present and ensure yearly sales performance., • Develop and grow the project pipeline for future growth., • Coordinate with Strategic planning and R&D to market relevant sales campaigns and product focus., • Adhere to the financial guidelines and policies of the company including DSO/DPO/DIO and debt monitoring., • Carry out your daily activities following the Commercial Playbook., • Coordinate and leverage collaboration between internal departments to ensure accurate and timely customer service and response to all customers., • Collaborate with internal functions to comply with both internal and external guidelines., • Educate yourself about the pharmaceutical industry and Suanfarma’svalue proposition to our customers Qualifications: • 2-3 years of Customer Service or Inside Sales experience, • Attention to detail and customer focus, • Understanding of sales and operations planning process, • Strong team player, • Problem solver with a positive attitude, • Skilled in Word, Excel, Powerpoint and Salesforce.com preferred, • Pharmaceutical industry experience preferred

Corporate Associate – Newark Sills Cummis & Gross P.C. is a full-service commercial law firm with offices in New Jersey, New York and Florida. At Sills Cummis & Gross, our goal is to make sure you are exposed to high-profile cases and receive the necessary tools to exceed client expectations. Our attorneys are innovative, creative, and collaborative; giving you the platform to flourish in an environment where your ideas matter. When you join our group of attorneys, you will work alongside some of the best professionals in their field of practice who will mentor you and help develop your skills. The Firm not only makes a commitment to our clients, we also make a commitment to our attorneys. If you are ready to join an engaging, inclusive firm where you will have the ability to shape your future, view our open positions and apply. The Firm’s highly credentialed and experienced corporate practice group attorneys handle a broad range of public and private transactional, compliance and corporate counsel assignments. Our clients are international and domestic investors, lenders, entrepreneurs and operating companies, from startups to small and midsized entities to Fortune 500 corporations. The Firm’s experience spans a diverse range of industries, including financial services, pharmaceutical and other life sciences, technology, insurance, real estate, construction, public utilities, health care, education, food and beverage, hospitality, media, consumer products and industrial manufacturing. Our Corporate Practice Group is seeking a highly skilled and motivated Corporate Attorney with 7+ years of experience to join our New Jersey office. The ideal candidate will have significant experience handling sophisticated transactional, advisory, and general corporate matters for emerging growth and established companies across a range of industries, including life sciences. Sills Cummis & Gross is an equal opportunity employer. Requirements • Represent clients in a broad range of corporate and transactional matters, including mergers and acquisitions, joint ventures, strategic alliances, restructurings, and general corporate counseling., • Structure, draft, and negotiate complex commercial agreements, including SaaS, licensing, distribution, supply, professional services, outsourcing, and product development agreements., • Counsel clients on corporate governance matters, shareholder arrangements, employment agreements, and related disputes., • Assist companies and investors with early-stage and venture capital financings, bank financings, strategic investments, and exit transactions, including mergers and acquisitions., • Collaborate closely with clients to provide practical, business-oriented legal solutions tailored to their objectives and industry context. Qualifications • 7+ years of relevant corporate transactional experience., • Must be admitted to the New Jersey bar; admission to the New York bar is strongly preferred (a plus)., • Strong experience in mergers and acquisitions, corporate governance, commercial contracts, and financing transactions., • Excellent drafting, negotiation, and client counseling skills., • Ability to manage multiple matters independently while working collaboratively within a team. Salary and Benefits • $240,000 – $280,000 annually, commensurate with experience., • We offer a comprehensive benefits package that includes medical, dental, and vision coverage, a 401(k) retirement plan, paid time off, and other firm-sponsored benefits and perks.

E*Pro Consulting service offerings include contingent Staff Augmentation of IT professionals, Permanent Recruiting and Temp-to-Hire. In addition, our industry expertise and knowledge within financial services, Insurance, Telecom, Manufacturing, Technology, Media and Entertainment, Pharmaceutical, Health Care and service industries ensures our services are customized to meet specific needs. For more details please visit our website www.epro-tech.com. Title : TABLEAU ADMIN Location : Newark, DE Type : Fulltime Permanent Work Status : US Citizen / GC / EAD (GC) Required Skills: • Experience of entire lifecycle (cradle to grave) with Tableau, • Experience with data architecture and data analysis skill sets, • Primary experience with industry BI/Reporting tool - Tableau, • Experience in OBIEE, Spotfire, MicroStrategy, Cognos, Actuate, SAS, SSRS, Informatica, • Expertise in Data Interoperability and Analytics, • Understanding of ITIL Service Management disciplines and practical experience in applying them, • Proven ability to independently champion business intelligence principles with business owners, application owners, data analysts and DBAs, • Certified Business Intelligence Professional (CBIP) accreditation, • Experience supporting financial applications, • Experience with Financial services data All your information will be kept confidential according to EEO guidelines.

Company Description Tadbik is a global leader in advanced packaging solutions, specializing in flexible packaging, premium labels, smart RFID technologies, and automation systems. With over 40 years of experience, we partner with renowned global brands across industries such as food, beverage, pharmaceuticals and cosmetics, With four manufacturing sites worldwide, Tadbik is committed to delivering high-performance solutions that drive brand differentiation and operational excellence. Responsibilities • Create and update quality control protocols, ensuring they are effectively communicated and followed throughout the production process., • Observe the printing process from start to finish, identifying potential issues, and ensuring adherence to established standards and customer requirements., • Conduct and document all QA/QC, safety, OSHA and ISO related trainings as defined in the current year training plan for all employees. Create training plan for following years., • Prepare for the annual external ISO 9001, ISO 14001, SQF Audits, • Collaborate with production staff to resolve quality issues, implementing corrective actions, and preventing recurrence., • Create, maintain and update all SOP’s for applicability to current operations, ISO standards, OSHA requirements and customer requirements., • Collect, track, and analyze quality data to identify trends, pinpoint root causes of quality problems, and implement corrective actions., • Communicate quality performance to management, providing feedback to production staff, and interacting with customers to address quality concerns., • Train employees on quality control procedures, providing guidance on best practices, and fostering a culture of quality. Requirements • Strong knowledge of Quality Assurance practices, including compliance with industry standards and regulatory requirements., • Proficiency in data analysis and problem-solving to identify quality trends and implement corrective actions., • Proven ability to lead and manage a team, with strong organizational and communication skills., • Familiarity with packaging/printing production processes., • Bachelor’s degree in a related field such as Engineering, Quality Management, or equivalent experience is preferred., • Experience in the food, beverage, or pharmaceutical industry is advantageous.

Job DescriptionManufacturing Associate II Allendale, NJ Lynkx Staffing specializes in placing Biotechnology, Pharmaceutical, Medical Devices, IT & Human Resources professionals in New Jersey. Under the supervision of the Associate Manager, the Manufacturing Associate II processes, cultures, cryopreserves and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance to facility GLP, GTP and GMP practices. Facility and personnel specific responsibilities will be regulated by company's policies or client procedures being performed at each Cellular Production Facility. The ideal candidate must have a collaborative and inquisitive nature, must possess excellent organizational and verbal and written communication skills and be flexible in their working hours. • Performs any and all required processing and manipulation required to produce and assess safe and efficacious products, • Proficiently functions within an ISO Class 7 and 6 clean room environments, ensuring personal and product safety, • Consistently produce a high level of documentation accuracy and clarity, • Performs cryopreservation of products using DMSO base solutions and controlled-rate freezers, • Proficiently operate and maintain equipment according to designed procedures. Assigned responsibilities could include but is not limited to COBE 2991 cell washer, Clinimacs cell separator, Elultra cell separator, controlled- rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, CO2 incubators, liquid nitrogen freezers, microscopes, pipets, wave bioreactors, refrigerators, ultra- cold freezers, water baths, tube sealers, dry shippers, centrifuges, sterile connection devices, • Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints, • Participating in clinical trial support and studies, may include but not limited to sample preparation, sample shipping, media and reagent preparation., • Thawing and/or washing cryopreserved hematopoietic cell products either at the Clinical Site or in the facility as specified by standard operating procedures, • Performing facility and equipment duties such as periodic maintenance, preventive maintenance, for applicable methods and equipment, reporting facility and equipment problems to Assistance Manager, trouble-shooting facility and equipment problems as specified in standard operating procedures, • Notifying Management of any deviation that may occur during processing or during equipment maintenance., • Applies knowledge of processing principles and techniques to make good judgement and appropriate decisions, • Performs investigations for deviations and complete deviations and CAPA’s (Corrective and Preventive Actions) in a timely manner, • Supports technology transfers into GMP manufacturing operations, • Participate in the on-call programREQUIREMENTS, • BA/BS or Associate's Degree in a biologics or related field preferred, • 2-4 + years of applicable experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing, • Current Medical Technologist license or equivalent is a plus, • Aseptic/cell processing and clean room experience preferred, • Demonstrates tact and courtesy in dealing with others, • Strong work ethic, methodical approach to new challenges, • GLP and GMP experience a plus, • Must be able to work independently and with minimal supervision, • Able to work in fast paced environment at times under pressure and with tight deadlines, • Excellent organizational skills and attention to detail, • Good verbal and written communication skills, • Strong team-oriented interpersonal skills are essential, • 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, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work a flexible schedule that may include nights, weekends and/or holidays, • Training Required; GMP, Gowning training/qualification, Aseptic process qualification (personal media fill), • 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 companyWorking EnvironmentMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work in the cleanroom environment for extended period of timeMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job 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 DescriptionValidation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device IT & Human Resources disciplines in New Jersey. The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing and QC lab equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. • Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc., • Execute IQ/OQ and /or PQ protocols, • Prepare final reports for executed protocols, • Prepare final reports for vendor IQ, OQ and/or PQ protocols, • Review of executed IQ/OQ/PQ protocols and raw data, • Perform periodic review/requalification of validated equipment, systems and cleanrooms, • Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met, • Assembling validation related documents; and filing/archiving approved documents, • Maintaining electronic records.REQUIREMENTS, • BS/BA in engineering or a related Science discipline, • 3-7 + years of validation experience, • Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc., • Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11., • Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary., • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management., • Must be a dedicated self-starter with a high energy level and able to achieve results., • Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution., • Good time management skills to manage and meet deadlines., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment., • Good computer skills and Microsoft Office knowledge., • Ability to multi-task team is essential., • Flexible and able to adapt to company growth and evolving responsibilities., • Highly organized, detail oriented, and ability to manage multiple priorities., • Ability to perform the job under direct or indirect supervision, • Must have the ability to work in a team-oriented environment and with clients, • Must have the ability to work with specialized equipmentMay occasionally work with pressurized systems. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.Ability to work in cleanroom environment for a moderate amount of time.Ability to lift, transfer, or ship validation equipment or related accessories.While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, or crouch. Must where PPE when appropriate. 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: AAF International offers the most comprehensive clean air solutions available across the globe. Selling under the American Air Filter® and the AAF International® brand names, AAF International has been an industry pioneer since 1921 with manufacturing operations in 22 countries and over 6000 employees globally. Our products are the industry benchmarks for quality and performance. Our applications include commercial, industrial and residential solutions from the filters used in your home to the most critical cleanroom and power generation applications. We are a member of the Daikin Group, the world's largest air conditioning provider with $30 billion in revenue and over 98,000 employees worldwide. Founded in 1924, Daikin has grown into a diversified industrial manufacturing company offering solutions in clean, air, air conditioning, refrigeration, chemicals, oil hydraulics, defense systems and electronics. Our culture of continuous improvement, safety and world class operations is driven by our people-centered management philosophy. This philosophy is built around mutual selection: that while AAF seeks top talent people to join and deliver on our team, we also want each team member to receive job satisfaction, growth & development, and continued happiness in being a long-term member of the AAF family. This is fueled by our belief in treating our people, our supply partners, our customers and our environment with the trust and respect we each require, and our passion to give back to our community for our success. Read more about our philosophy at: http://www.daikin.com/about/corporate/philosophy/index.html AAF International is an Equal Opportunity Employer M/F/Disability/Veteran. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, sexual orientation, gender identity, national origin, citizenship, veteran status, uniform servicemember status, age, disability or any other legally recognized protected personal characteristics. Position Objective: This position will report to the regional branch in New Jersey and work out of their home, ideally located in the territory. The territory for this position covers Nassau and Suffolk counties and the outer boroughs of Queens, Brooklyn, Bronx and Staten Island. Achieves maximum sales profitability, growth and account penetration within an assigned territory and/or market segment by effectively selling the Company’s products. Contacts and secures current and new business accounts/customers. Key Accountabilities: • Promotes/sells/secures orders from existing and prospective customers through a relationship-based sales approach highlighting the advantages/value proposition., • Demonstrates products to existing and potential customers and assists them in selecting those best suited to their needs., • Manages sales goals - profit and budget expenses., • Establishes, develops and maintains business relationships with current customers and prospective customers in the assigned territory/market segment to maintain current and generate new business., • Researches sources for developing prospective customers and for information to determine their potential., • Develops clear and effective written proposals and quotations for current and prospective customers., • Expedites the resolution of customer problems and complaints., • Coordinates sales effort with marketing, sales management, accounting, logistics and technical services., • Analyzes the territory/market’s potential and determines the value of existing and prospective customers to the Company., • Creates and manages a customer value plan for existing customers highlighting sales profile, share and value opportunities., • Provides management with detailed information on customer needs, problems, interests, competitive activities, and potential for new products., • Stays current with product applications, technical services, market conditions, competitive activities, and marketing trends and activities., • Participates in trade shows and conventions as required., • Perform other related duties as assigned as required. Requirements: Position Requirements: • Bachelor’s degree from an accredited university in Business or related field preferred;, • 5+ years' prior selling experience;, • Understanding and experience with high value-added product selling, pricing, and negotiation;, • Experience selling to healthcare and pharmaceutical facilities a plus;, • Ability to communicate a technical concept or value added benefit to achieve buy-in from diverse teams to meet sales targets and profitability;, • A history of consistently delivering on expectations for growth and profitability must be demonstrated;, • A team player that possesses a natural way of influencing, both internally and externally;, • A self-starter with a creative eye to implement marketing and promotional campaigns designed to achieve specific growth objectives regionally and nationally;, • Must be proficient in Microsoft Office (Word, Excel, PowerPoint);, • SAP or CRM experience, Salesforce preferred.

Job Description Senior Structural Engineer We are seeking a Senior Structural Engineer with strong experience in temporary structures, including scaffolding systems, shoring, bracing, and construction support design. This role involves working closely with contractors, project managers, and field teams to develop safe, efficient, and code-compliant solutions for complex construction projects. Responsibilities • Design and analysis of temporary structures including scaffolding, shoring, formwork, and excavation support systems, • Perform structural calculations and prepare detailed drawings and specifications, • Review contractor submittals and provide engineering support during construction, • Conduct site visits to assess conditions and ensure compliance with design intent, • Collaborate with multidisciplinary teams to support project delivery, • US citizen or green card a must., • Ensure all work meets applicable codes, standards, and safety requirements Qualifications • Bachelor’s degree in Civil or Structural Engineering, • Professional Engineer (PE) license required, • 8+ years of structural engineering experience with a focus on temporary structures or construction engineering, • Strong knowledge of OSHA regulations and relevant building codes, • Proficiency with structural analysis and design software, • Excellent communication and problem-solving skills This is an excellent opportunity to work on challenging projects with a focus on construction safety and innovation. To apply, submit resume to Joseph P. Durkin Liberty Personnel Services, Inc. 1001 Conshohocken State Rd, Ste 2-410 West Conshohocken, PA 19428 Direct Line: #midsenior #CivilMEP #li-hybrid Company DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (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 team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.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 Summary: Instrument and Controls Engineer:The Instrument and Controls Technician is involved with the successful daily operation of the oil refining facility, and the modification and alteration of the plants automated control and power systems to accommodate business needs and ensure high plant availability. This requires close collaboration with other employees and management staff to ensure safe work and to set or re-set job priorities. Documentation, as required to document changes in plant physical or logic changes, and documentation to meet our goals of safety first, quality work and compliance with our customers’ requirements and concerns. Qualifications: Instrument and Controls Engineer: • High School Diploma or GED with at least 10 years I&E (I&C) experience in a chemical, food, pharmaceutical manufacturing environment. Familiarity with PLC based controls systems such as GE or Allen Bradley in a manufacturing environment., • Ability to analyze and interpret technical problems related to instrumentation or PLC logic., • Ability to read and understand company policies and procedures, technical datasheets or literature, P&IDs, electrical drawings (One-line drawings, loop drawings, control circuits, etc), • Ability to effectively present information either verbally or via written document (e-mail, MS Word/Excel, CMMS, etc) and respond to questions from groups of managers, co-workers, customers, and the general work force., • Ability to work with and apply mathematical concepts to practical situations., • Preferred: New Jersey Licensed Electrician (or working towards license), • Preferred: ISA Certification (Certified Control System Technician, Certified Industrial Electrician, Certified Instrument Technician)Duties & Responsibilities: Instrument and Controls Engineer:, • Monitor, repair, maintain and troubleshoot all field instrumentation, electrical equipment and controls systems including plant safety systems and plant power systems., • Install, loop check, maintain and troubleshooting process control systems comprised of transmitters, controllers, and valves operating in a PLC system., • Calibrate, monitor, repair, maintain, label and document all field instruments such as transmitters, controllers, valves, PLCs, plant safety systems, plant power systems, utility systems (HVAC), pH and conductivity meters, • Install, maintain, and troubleshoot electrical distribution and protection circuits up to 480VAC., • Fabricate and install rigid and flexible conduit, and run power and control wiring based on electrical code requirements, • Properly select, install and wire 120V-480V motors, single phase to three phase based on needs, • Strong working knowledge of National Electrical Code (NFPA 70), • Evaluate current instrumentation technology for process equipment and make recommendations for improvements., • Ensure all work orders are completed, documented and closed out in the site CMMS system, as per procedure., • Provide on-call support during assigned weeks to ensure 24/7 coverage, • Provide practical solutions to operations/ controls problems., • Scope, estimate and execute small capital / maintenance projects along with maintenance manager/ project director/ operations, etc., • Train other employees considering their needs and company needs., • Oversee the work by contractors as required on site to ensure safe and quality performance., • Look for opportunities to help work get done safer, faster and more cost effectively. Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position We are seeking an experienced cardiometabolic Medical Science Liaison (MSL) to join an exciting opportunity within our Medical Affairs (MA) team and work in a dynamic and collaborative environment. This is a field-based position and the candidate must be located within one of the territories. MSLs are responsible for developing professional relationships with healthcare professionals through scientific engagement to support clinical stage and launch molecules. MSLs engage healthcare professionals through scientific exchange and provide clinical and scientific support. Responsibilities • Engage with cardiologists / endocrinologists / healthcare professionals / stakeholders to educate on clinical and scientific evidence to advance treatment landscape as aligned with strategic imperatives., • Educate on RNAi technology, hypertriglyceridemia, familial chylomicronemia syndrome, and hypercholesterolemia., • Synthesize and communicate clinical and scientific insights to internal stakeholders., • Attend and present at scientific congresses and meetings to stay up to date with the latest scientific developments and trends in cardiometabolic therapeutic area., • Respond to unsolicited inquiries consistent with MSL compliance standards., • Support company sponsored clinical trials through investigator site engagement., • Support speaker training as requested and ensure speakers are up to date with evolving disease and product data., • Support national, regional, and local scientific congresses including Opinion Leader (OL) engagement, session coverage, booth, and company debriefs., • Monitor and analyze scientific publications, clinical trials, and competitive landscape in the cardiometabolic therapeutic area., • Maintain clinical and scientific expertise and general industry business acumen., • Advance MSL value proposition, demonstrate tact and professionalism, and deliver results., • Act in accordance with company policies, • Develop territory specific OL and account plans including OL profiles, pre-call planning, and follow up plans., • Communicate clinical and scientific information in an accurate and clear manner., • Document MSL quantitative and qualitative accomplishments., • Provide scientific support for Med Info inquiries, ensuring accurate and timely responses to healthcare professionals' queries., • Develop scientific content for medical education initiatives., • Support Medical Affairs as needed with special projects and initiatives., • Sophisticated cross-functional relationship management is critical for success. Requirements • PhD, PharmD, MD, or DO degree required, • 5 years of experience as an MSL, • Cardiometabolic therapeutic experience, • Industry experience in Medical Affairs at a biotech or pharma, • High level verbal and written communication skills., • Ability to effectively collaborate in a dynamic environment., • Strong comprehension of cardiometabolic therapeutic area., • Ability to interpret key scientific data and translate the findings to meet educational and research needs to affect corporate research strategic activities/decisions., • Ability to identify the unmet medical, educational, and research needs at a local & regional level in the medical community., • An understanding of the health care delivery system, including the managed care arena and its impact on patient care, regional medical care and the pharmaceutical industry., • Understanding of the design and execution of research studies and strategic implications., • Proven ability to drive results at a high level of quality as a strategic and creative thinker., • Demonstrates ability to deal with ambiguity and thrive in an ever-changing environment., • Strong project management skills with demonstrated ability to manage projects and/or colleagues in successful implementation of business-critical projects., • Strong time management & organizational skills., • Ability to travel.Pay Range $190,000—$210,000 USD Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy

Job DescriptionAbout the Company LTS is a global leader in transdermal and oral thin‑film drug delivery technologies. Our teams have pioneered breakthroughs such as the first contraceptive patch, nicotine patch, oral active ingredient film, and Parkinson’s patch. When you join LTS, you become part of a team that continues to shape the future of patient care and bring life‑changing therapies to market. At LTS, our purpose drives everything we do: We CARE. We CREATE. We DELIVER. We’re committed to fostering an employee experience that reflects our innovation — supportive, collaborative, and empowering. Across our New Jersey and Minnesota locations, you’ll work alongside knowledgeable experts on diverse projects in an environment where every day is different and your contributions truly matter. Cost Analyst- Pharmaceutical Manufacturing; North America Position Overview LTS is seeking a detail-oriented Cost Analyst to support financial decision-making across manufacturing, operations, projects, and administrative functions. In this role, you will analyze costs, investigate variances, support budgeting and forecasting, and provide insights that help improve efficiency and profitability. This position is based in West Caldwell, NJ and is hybrid eligible after the introductory period is complete; up to 2 days/week. Schedule: Monday–Friday, 8:00 AM–4:30 PM What You Will Do: • Generate and maintain detailed actual cost analyses and cost models to support product and service quoting., • Analyze actual expenses against targets, plans, and forecasts; identify discrepancies and recommend improvements., • Investigate manufacturing order variances, scrap, project hours, and expense variances., • Assist with annual budgets, forecasts, and project cost estimates., • Identify and support cost-saving strategies to improve efficiency and margins., • Prepare reports and present analysis and insights to management., • Monitor inventory, labor costs, indirect expenses, and trends to support business decisions.Minimum Qualifications:, • Bachelor’s degree in Accounting, Finance, or a related field, • Minimum 5 years of relevant experience in cost accounting, finance, or cost analysis in a manufacturing environment., • At least 2 years' experience with SAP S/4HANA, • Strong analytical and Excel skills, • Strong written and verbal communication skillsPreferred Qualifications, • Experience in pharmaceutical manufacturing or a GMP-regulated environment, • Experience supporting manufacturing or operational finance in a complex business environment If this sounds like you, we want to hear from you! LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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

Job Description A growing pharmaceutical company with a strong mission-driven culture is hiring a Director of Network and Infrastructure Operations to take ownership of network operations across the Americas region. This is a highly visible infrastructure leadership role supporting business-critical environments across research, manufacturing, labs, corporate offices, commercial operations, and cloud platforms. This is a strong fit for a network leader who enjoys both strategy and execution: setting direction, improving reliability, strengthening security, managing vendor performance, and making sure the network is ready for the business, not constantly chasing it from behind. The environment is modern, complex, and global, with meaningful work around SD-WAN, cloud connectivity, Zscaler, Zero Trust, segmentation, monitoring, business continuity, and network modernization. The right person will have the opportunity to influence standards, improve operations, and be the Americas voice in global infrastructure planning. This is a direct hire role based in Clifton, NJ with a hybrid schedule 3 days onsite each week. The Role You'll Play As the Director of Network and Infrastructure Operations, you will be responsible for end-to-end leadership of network infrastructure operations across all Americas sites. You will own the regional hybrid network ecosystem, including SD-WAN, LAN/WAN, wireless, cloud connectivity, remote access, Zscaler, firewalls, DNS/DHCP/IPAM, IDS/IPS, NAC, NDR, and secure internet egress infrastructure. You will report to the Americas Infrastructure Lead & Global Network Lead and work closely with U.S. regional leads, global infrastructure teams, IT Security, site leadership, network vendors, and managed service partners. Key responsibilities include: Lead Americas network operations across SD-WAN, LAN/WAN, Wi-Fi, remote access, Zscaler ZIA/ZPA, and AWS cloud network connectivity Ensure high availability, reliability, and performance of critical network services across research, manufacturing, labs, corporate offices, commercial operations, and cloud workloads Oversee network incident, problem, and request management, including escalation paths, service desk runbooks, KB documentation, and root cause analysis Implement proactive monitoring, telemetry, logging, alerting, and performance optimization using tools such as ThousandEyes, SolarWinds, Zscaler analytics, and CloudWatch Maintain standardized network configurations aligned with global architecture, Zero Trust, segmentation, firewall policies, and secure internet egress requirements Lead regional network budgeting, forecasting, operational spend management, licensing, carrier contracts, and cloud networking cost control Manage vendors and managed service partners, including carriers, SD-WAN providers, Zscaler, firewall partners, monitoring vendors, SLA performance, QBRs, renewals, and service onboarding Ensure connectivity resilience and disaster recovery readiness through redundant WAN paths, HA firewall clusters, diverse internet egress, SD-WAN failover, DNS/DHCP/IPAM recovery, and cloud routing restoration Serve as the primary liaison between site operations, global network engineering, cloud networking teams, IT Security, procurement, regional leadership, and business stakeholders Plan and execute regional network projects, including SD-WAN upgrades, Zscaler policy rollouts, firewall refreshes, wireless modernization, cloud connectivity expansion, and site readiness initiatives Partner with Security to maintain a strong network security posture, support vulnerability remediation, enforce least-privilege access, and ensure compliance with audit, GxP, regulatory, and enterprise security requirements Mentor regional infrastructure personnel, support workforce planning, build technical capability, and foster a culture of ownership, operational discipline, customer focus, and continuous improvement Background Profile The ideal candidate is a senior network infrastructure leader with deep hands-on technical experience, strong operational discipline, and the ability to lead teams, vendors, and global stakeholders in a complex enterprise environment. Bachelor's degree in IT, Computer Science, or a related discipline 10+ years of experience leading network engineering and operations teams in a complex, multi-site enterprise environment Deep expertise in SD-WAN, LAN/WAN, Wi-Fi, firewalls, DNS/DHCP/IPAM, cloud networking, and hybrid network design Practical experience with AWS and Azure cloud networking, including VPC/VNet design, routing, security controls, and hybrid connectivity models Experience with Zscaler ZIA/ZPA, Zero Trust access models, and secure internet egress architectures Strong understanding of network security, segmentation, identity-based access controls, and cybersecurity integration Proven ability to lead technical teams and manage vendor partnerships Strong troubleshooting, stakeholder communication, and operational leadership skills Familiarity with regulated environments and audit requirements Preferred experience includes: Experience in pharmaceutical, biotech, manufacturing, or another regulated sector Experience managing MSP-driven operating models Familiarity with Fortinet, Cisco, Aruba, AWS/Azure networking tools, Zscaler, and enterprise monitoring solutions ITIL certification or experience with ITIL-based processes Project management or leadership training certifications

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 Description A growing global pharmaceutical company is hiring an Associate Director of Infrastructure and Cloud Operations for the Americas region. This is a high-visibility role supporting cloud, data center, infrastructure operations, and infrastructure engineering across the U.S., Canada, Mexico, and Brazil. The organization is continuing to modernize its infrastructure environment, with a strong emphasis on cloud adoption, hybrid infrastructure, operational resiliency, scalable enterprise platforms, and stronger alignment between regional execution and global IT strategy. This role will be important in helping the Americas region support business-critical infrastructure while also contributing to broader cloud modernization and operational maturity efforts. This is a strong opportunity for someone who enjoys working across both strategy and execution. The role will support AWS, Azure, hybrid cloud, data center services, cloud migration, infrastructure modernization, vendor management, budget ownership, and partner-led delivery models. It is not a pure management role, and it is not a purely hands-off architecture role. The company needs someone who can provide senior technical leadership, guide delivery teams, challenge vendors, manage costs, and stay close enough to the work to ensure strong execution. While there are no direct reports currently assigned to this role, the position will lead and coordinate a large ecosystem of outsourced partners, consultants, and offshore resources. The role will also play an important part in helping the company build operational and engineering capability through its Global Capability Center model. This is a direct hire role based in Clifton, NJ with a hybrid schedule of three days per week onsite. The Role You'll Play The Associate Director, Infrastructure and Cloud Operations, will be responsible for leading cloud and data center services across the Americas region. This person will partner closely with global infrastructure leadership, regional IT leaders, security, application teams, vendors, and managed service partners to ensure the company's cloud and infrastructure environment is reliable, scalable, secure, and aligned with global strategy. This role owns both operational and engineering responsibilities for infrastructure services across the region. It requires a strong technical foundation in AWS, Azure, hybrid cloud, data center operations, automation, and cloud-native infrastructure, along with the leadership ability to manage vendors, budgets, contracts, service delivery, and large partner teams. Key responsibilities include: Lead cloud and data center infrastructure operations across the Americas region, including the U.S., Canada, Mexico, and Brazil, with responsibility for AWS, Azure, hybrid cloud, and on-premise data center environments. Partner with the Global Cloud and Data Center Lead on regional infrastructure strategy, cloud modernization, operational execution, roadmap planning, and alignment with global standards. Drive the transition from on-premise infrastructure toward scalable cloud-native, hybrid cloud, and multi-cloud solutions, including migration planning, infrastructure modernization, and technical architecture guidance for AWS and Azure build solutions. Support infrastructure needs tied to enterprise applications, analytics, big data, machine learning, and other business-critical platforms, ensuring services are designed for availability, resiliency, performance, scalability, security, and compliance. Oversee regional infrastructure operations across US data center locations and drive operational excellence in incident, problem, change, service delivery, monitoring, documentation, runbooks, and continuous improvement. Lead and coordinate outsourced partners, consultants, managed service providers, and offshore teams, setting clear expectations around service delivery, accountability, documentation, and performance. Help mature operational and engineering capabilities through the company's Global Capability Center model. Manage cloud and infrastructure budgets, forecasting, procurement, vendor agreements, contract renewals, maintenance agreements, software, hardware, service contracts, cloud spend, and delivery cost estimates. Partner with IT Security, compliance, architecture, application teams, and global infrastructure teams to ensure infrastructure solutions meet enterprise, regulatory, privacy, audit, GDPR, and security requirements, while communicating priorities, risks, project status, performance, and roadmap recommendations to leadership. Background Profile: The ideal candidate is a strong cloud and infrastructure leader who has grown through hands-on technical roles and can still go deep when needed. This is not a pure people management role and not a pure strategy role. The company needs someone who can provide technical oversight, make architecture decisions, manage partners, drive execution, and still understand the details well enough to challenge vendors and guide delivery teams. The right person will likely come from a similar-size enterprise environment with a lean IT operating model, heavy use of outsourced/offshore partners, and a need for both strategic planning and hands-on technical leadership. This person should be comfortable operating with visibility across regional and global leadership while also staying grounded in practical infrastructure delivery. 8+ years of progressive IT infrastructure experience, including 3+ years in a cloud architect or senior cloud infrastructure architecture capacity. 2+ years of technical leadership experience, which may include leadership of offshore teams, outsourced partners, consultants, project teams, or direct reports. Strong hands-on experience with AWS, along with experience supporting Azure, hybrid cloud, multi-cloud, and cloud infrastructure build solutions. Experience designing, building, supporting, and modernizing infrastructure across cloud, data center, compute, storage, backup, disaster recovery, monitoring, automation, and enterprise operations. Experience planning or executing migrations from on-premise systems to cloud-native or cloud-based solutions. Experience supporting infrastructure services in complex, multi-site enterprise environments with large user populations and partner or consultant ecosystems. Ability to manage both infrastructure engineering and operations responsibilities, including incident management, service delivery, technical execution, and operational improvement. Experience leading vendors, managed service providers, consultants, and outsourced partner teams. Strong understanding of infrastructure cost management, cloud spend, budget forecasting, contract renewals, procurement, vendor agreements, and delivery cost estimation. Strong project management, communication, and stakeholder management skills, with the ability to lead infrastructure initiatives across regional leadership, global IT, technical teams, security, and business stakeholders. Preferred experience and skills: Experience in pharmaceutical, biotech, life sciences, healthcare, manufacturing, or another regulated environment, including exposure to GDPR, GxP, audit requirements, privacy, or regulated infrastructure controls. Experience supporting big data, machine learning, analytics, advanced cloud-based data platforms, or other emerging infrastructure needs. Experience helping build or mature a Global Capability Center, offshore delivery model, shared services model, or global IT operating structure. Experience in a lean enterprise IT environment where the role requires both senior-level oversight and hands-on technical involvement. Experience with scripting, automation, infrastructure as code, cloud governance, cloud security, and operational monitoring, including tools or languages such as Python, Perl, or shell scripting.

Job Description Associate Director of Billing & Collections Services - Law Firm - $180-225k - Hybrid Schedule As the Director of Billing and Collections, you will handle serve as a critical revenue operations executive responsible for leading and optimization of the firm’s end-to-end billing, electronic invoicing (e-billing), and accounts receivable functions. This role partners closely with executive leadership, practice group chairs, and partners (shareholders) to maximize Work-in-Progress (WIP) conversion, drive cash realization, and ensure compliance with strict client outside counsel guidelines. The ideal candidate pairs deep technical mastery of law firm billing systems with the professional poise necessary to advise and influence high-performing legal stakeholders. MANDATORY SYSTEM REQUIREMENT CRITICAL ELIGIBILITY NOTE: Candidates must possess verified, advanced hands-on operational proficiency in Aderant Expert. This requirement is strict and non-negotiable. Applicants without deep, recent experience utilizing and navigating Aderant Expert infrastructure to drive legal revenue operations will not be advanced. ESSENTIAL FUNCTIONS & RESPONSIBILITIES1. Revenue Systems Leadership & Aderant Management Serve as the primary functional business owner and subject matter expert for the Aderant Expert financial management platform. Partner with the IT and financial systems departments to configure, troubleshoot, and maximize the utilization of Aderant modules and integrated utilities (e.g., BillBlast, Billstream, and star*collect). Direct the structured monthly pre-bill/pro-ration cycle; track partner review timelines and enforce strict internal deadlines to accelerate time-to-invoice. Manage and orchestrate the month-end and year-end close procedures for billing and cash receipts, ensuring complete transactional accuracy and operational speed. 1. Portfolio Collection Strategy & Risk Management Formulate and execute firm-wide collection strategies designed to systematically compress aged accounts receivable (A/R) and inventory over 90 days. Exercise formal approval authority over billing write-downs and A/R write-offs within pre-established corporate threshold parameters. Direct deep-dive reviews of outstanding balances and partner directly with billing attorneys to diplomatically settle underlying client billing disputes. Maintain rigorous surveillance over high-exposure balances, generating structured case notes and action plans for items exceeding $100,000. 1. E-Billing & Compliance Operations Oversee complex corporate electronic invoicing operations across major vendor clearinghouses (e.g., Legal Tracker, Tymetrix, CounselLink, and Passport). Identify structural revenue leakage by proactively diagnosing, auditing, and correcting systematic e-billing line-item rejections and compliance errors. Monitor client outside counsel guidelines to ensure the billing team and timekeepers configure system-level validation rules correctly in Aderant. 1. Leadership & Lateral Integration Recruit, train, professionalize, and mentor a multi-office team of billing coordinators, e-billing specialists, and professional collections analysts. Establish clear key performance indicators (KPIs) for the billing and collections teams to track accuracy, volume, and processing cycle times. Conduct custom financial and operational onboarding orientations for incoming lateral partners to guarantee seamless assimilation of their client portfolios into the Aderant ecosystem. 1. Executive Reporting & Analytics Prepare and present comprehensive monthly aging, realization, utilization, and cash forecast metrics to the CFO, Managing Partner, and General Counsel. Deliver data-driven analytics detailing individual practice group and partner financial performance to support firm leadership's strategic decisions. REQUIRED MINIMUM QUALIFICATIONS Software Mastery: 8+ years of direct, advanced operational experience using Aderant Expert in a law firm administration or heavy power-user capacity. Direct experience with integrated utilities like BillBlast and ARCS/star*collect is highly preferred. Professional Experience: 8 to 10+ years of progressive financial or revenue operations leadership, with at least 5 years of recent management experience inside a mid-sized commercial or AmLaw 200 firm. Education: Bachelor’s degree in Accounting, Finance, Business Administration, or a closely related discipline. To apply, please send your resume and references to . Connect with me on LinkedIn I look forward to connecting with you! Click here for my HOT JOBS! Dan Urban Liberty Personnel Services, Inc. 1001 Conshohocken State Rd, Suite 2-410 West Conshohocken, PA 19428 Call or Text: – Direct Ext 119 - Main www.libertyjobs.com #legal #director #hybrid #libertyjobs Company DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

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

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

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

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

Job Description Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a energy and utility company in Newark, NJ. This is a Hybrid role see details below. This role will be onsite and available to candidates local to the Newark, NJ area. We are interested in every qualified candidate who is eligible to work in the United States. Unfortunately, we are not able to sponsor visas or employ corp-to-corp Business Development Manager - Energy Efficiency Program Support Manager Location: Hybrid – Newark, NJ - 1 day per week Supporting Clients in Central and South New Jersey 12 Month Contract Pay Rate: $60-$65/hr w2 Mileage Reimbursement Job Summary Oversee the performance of vendor(s), both office and field, that have been contracted to deliver program services Ensure vendor and employee compliance with safety protocols and practices Lead and participate in cross-functional teams, including other RES members, Customer Care, Contracting, Procurement, Legal, Marketing, IT etc, as required to deliver program services Enhance program delivery/customer experience and resolve business/customer issues Develop and maintain the processes for implementing energy efficiency projects and programs in accordance with requirements for BPU approved programs Provide oversight for business controls, process improvement and compliance Ensure accurate invoice processing Identify and implement process improvements and automate where possible Monitor program Key Performance Indicators to ensure program delivery meets business plan expectations Prepare and present program and project status reports to senior management Assist with special projects as necessary This leader must foster an inclusive work environment and respect all aspects of diversity. Must demonstrate and value differences in others' strengths, perspectives, approaches, and personal choices During storm restoration efforts, may be required to perform functions outside of routine duties and on a schedule that may be different from normal operation Job Responsibilities Oversee the performance of vendor(s), both office and field, that have been contracted to deliver program services; manage employee performance; ensure safety protocols and practices are followed. Lead and participate in cross-functional teams, including other RES members, Customer Care, Contracting, Procurement, Legal, Marketing, IT etc, as required to deliver program services, enhance program delivery/customer experience and resolve business issues. Develop and maintain program processes. Provide oversight for business controls, process improvement and compliance. Ensure accurate invoice processing. Identify and implement process improvements and automate where possible. Monitor program Key Performance Indicators to ensure program delivery meets business plan expectations and regulatory requirements; Prepare and present program and project status reports to senior management. Required: B.S. Degree in Management, Engineering, Business, Finance or other relevant field or equivalent work experience plus 7 years of experience in the space of energy efficiency programs, construction, or related fields. In lieu of a degree, 11 years of experience in the space of energy efficiency programs, construction, or related field. Experience managing vendor performance, and leading cross-functional teams; Energy Efficiency or Electric Vehicle program experience Management/leadership experience working with cross-functional teams Valid US driver's license Desired: Certified Energy Manager (CEM) certification MBA or Advanced Degree 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 DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Electrical Factory Inspector (Remote/Travel) responsibilities include, but are not limited to, the following: • Support department objectives and company goals, • Be a team player, • Sustain a positive, enthusiastic and professional attitude at all times, • Accommodate requests with a smile and “let me see what I can do” attitude, • Adhere to manager directives, • Maintain a professional appearance and demeanor, • Arrive on time, properly dressed and prepared to work, • Perform all duties in a timely, accurate, honest and professional manner, • Communicate with customers professionally and in accordance with customer service standards, • Be respectful to others Primary Tasks/Responsibilities: • Surveillance inspections of factories to assure products remain in compliance with conditions of granted certification., • Other duties assigned by management.Qualifications Basic Minimum Education Qualifications: • Two-year college degree or four-year college degree required Basic Minimum Qualifications: • Knowledge of electronics, • Certification in Electronics, ideal but not required, • Willing to travel - This position requires 90% - 100% travel, • Able to rent a car, • Willing to work overtime and remote, • Cannot be on any no fly list, • Clean driver record, • Authorization to work in the United States indefinitely without restriction or sponsorship. The Ideal Candidates Possesses the Following: • Ability to maintain confidentially, • Needs to be receptive to and accepting guidance from others, • Ability to deal with difficult people and problems, • Able to work well in a team environment, • Able to work in a diverse group of people, • Attention to detail, • Ability to multi-task and prioritize assignments, • Professional appearance Physical Qualifications: • Able to sit or stand for long periods of time, • Able to lift up to 30 pounds Additional Information Position is full-time travel & hybrid, working Monday - Friday 8:00 am to 5:00 pm, with overtime as needed. • Compensation: $50,000 - $70,000, • Excellent full-time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match, • Paid vacation and holidays Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients. Want to help us make a difference? Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients. Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles. We are looking for our next Operations Manager within our Operations Team. The Operations Manager will be responsible for providing leadership and direction for the site's technical operations team and driving plant continuous improvement initiatives. The role directs and coordinates all activities of the process and automation engineers and partners with the Manufacturing Technology team and Capital Engineering team to ensure proper prioritization and technical oversight of operations and ensure continuous improvement activities are on track. The Operations Manager is a key member of the Newark site leadership team and supports and establishes a strong safety and productive culture. This position is located in Newark, Delaware. Compensation: The current salary range for this role is estimated to be $146,367 - $176,052. In addition, this position may also be eligible to earn performance-based incentive compensation. The specific compensation offered to a candidate will be influenced by a variety of factors including but not limited to skills, qualifications, experience, and location. What You'll Do: • Serves as proactive member of Management Team by providing technical expertise, continuous improvement leadership, and identifying and acting upon cost saving opportunities;, • Actively participates on the Site Leadership team to set direction and optimize overall site productivity;, • Shows courageous leadership by coaching, asking questions, and intervening when needed., • Challenges status quo and past norms to make the operation more safe and effective:, • Utilize process knowledge to drive performance with technical support teams;, • Interacts with other members of the leadership team, plant staff, and divisional cross-functional groups to optimize plant operations;, • Drive enforcement and continuous improvement of the Roquette Operating System for the site;, • Lead GEMBA program for leaders and managers;, • Ensure effective determination and implementation of operations corrective and preventive actions (CAPA);, • Lead and coordinate sitewide 5S activities;, • Ensure timely and effective execution of operations RCA investigations;, • Lead site efforts for productivity improvement plans and VCP (value creation plan);, • Lead technical team to continuously improve plant OEE;, • Ensure operations department objectives are aligned with site and business direction;, • Improve operations efficiencies and develop and implement best practices;, • Ensure effective daily management of the Operations technical team, which includes technical staff, and resident contractors when applicable;, • Provide technical expertise to analyze and resolve recurring issues that impact plant uptime;, • Implement Lean concepts, improve equipment reliability, operations productivity and optimize overall asset life cycle costs;, • Lead team to provide technical support in order to plan department operations;, • Lead team to provide data needed for bill of materials, yield, OEE, and other key metrics;, • Create, review, manage and share sitewide KPI's;, • Reviews production and operating reports and resolves operational, manufacturing, and maintenance problems to ensure minimum costs and prevent operational delay;, • Continuously works to improve the total cost of production (raw material, conversion cost and activity rate, etc.). May take a leadership role in maintaining the budget as delegated by the Site Leader;, • Develops strong partnerships with support functions such as EHS, Maintenance, Supply Chain, and others to drive improvement in the organization and assure alignment;, • Provide operational resources to support investments in projects that improves quality and capability to meet internal and external customer needs and corporate, group, division and site goals;, • Ensures the operation team is fully prepared for immediate response situations, including where technical resources might be needed to analyze process conditions and guide the response;, • Encourage identification and prevention of non-conformance to quality procedures and specifications;, • Ensure that investigations are conducted into any process deviations or non-conformances and develop and implement programs to prevent re-occurrence;, • Understand and anticipate customer needs and implement performance measurements responsive to such needs;, • Communicate continuous improvements in key measurements including on time delivery, product quality and process capability; What You'll Need: Education: • B.S. Degree in Chemical Engineering (highly preferred), Chemistry or related technical discipline or equivalent combination of education and experience., • Minimum of 7 years in a chemical manufacturing or processing facility (food, flavors, cosmetic, chemical, or pharmaceutical environment preferred) with a minimum of 10 years of progressive management experience in line or staff position. Experience: • Experience in food/pharma manufacturing operations preferred., • 5+ years' experience in an industrial setting in a learning, EH&S, Manufacturing, HR, Quality or work process related role preferred;, • Strong analytical, personal computer, organizational and leadership abilities., • Strong communication skills (written, verbal, and listening) and interpersonal skills., • Strong problem-solving ability., • Expert knowledge of process technology and Avicel manufacturing preferred., • Strong project management and communication skills;, • Ability to manage time, balance priorities, and manage conflict;, • Good analytical skills with demonstrated ability to consistently solve problems in a decisive and efficient manner;, • Computer skills (word processing, spreadsheets, graphics & database);, • Good working knowledge and understanding of Enterprise Resource Planning (ERP) systems with working knowledge of SAP highly desirable;, • Lean Six Sigma experience a plus;, • Experience in heavy industrial or chemical technical applications;, • Experience managing in a Union environment a plus;, • MBA helpful but not required. Work Environment • This role spends approximately 70% of the time in an office environment and 30% of the time in the plant environment. Physical Demands • While performing the duties of this job, the employee is required to speak or hear. The employee is frequently required to stand; walk, climb stairs, use hands and fingers to handle or feel; and reach with hands and arms; work in hot, cold and loud environments. Position Type/Expected Hours of Work • This is a full-time on-site position. Days and flexible hours of work are required to meet facility demands. AAP/EEO Statement Roquette is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. "AAP, EEO, Drug-Free Workplace" Other Duties 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. If you identify yourself in this position, please apply byuploading your resume and let's start the journey together! Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences. Roquette strives to create a dynamic workforce while remaining firmly committed to equal opportunity by complying with EEO laws. As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach. To find out more about our products, values and sustainable development ambitions visit us at and at

Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients. Want to help us make a difference? Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients. Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles. We are looking for our next Environmental, Health, and Safety Specialist within our Environmental, Health, and Safety Team. The Environmental, Health, and Safety Technician will be responsible for managing, improving, tracking, consult and maintain programs, initiatives and engagement related to site safety, health, environmental, and site security to protect employees and the environment as well as support compliance with local, state and federal regulations. This role will have primary responsibilities to support and lead the site's EH&S programs. This position is located in Newark, Delaware. Compensation: The current salary range for this role is estimated to be $95,000-125,000. In addition, this position may also be eligible to earn performance-based incentive compensation. The specific compensation offered to a candidate will be influenced by a variety of factors including but not limited to skills, qualifications, experience, and location. What You'll Do: • Accurately maintains Environmental, Health, and Safety (EHS) hard copy and electronic recordkeeping., • Provides training coordination using company software tools. This includes training scheduling, course and quiz development, ensuring proper documentation., • Provide administrative support to the Site Contract Administrator. Will maintain training records, coordinate contractor vetting using ISN, update contractor status spreadsheet, maintain vendor electronic files, and track hours of operation., • Provide administrative support for medical surveillance program. (Maintain spreadsheets, distribute paperwork, schedule appointments)., • Coordinates safety milestone, initiative, and recognition programs., • Manage Safety Data Sheet system and inventory., • Enter and track documentation for Behavioral Based Safety Program, • Manage tracking of safety and housekeeping programs and closure of action items., • Contact for First Aid Supply vendor. Perform AED inspections., • Order EH&S supplies and services., • Assists in administration of the site's security badge system., • Facilitate development and implementation of site's annual EH&S Continuous Improvement plan., • Support implementation and maintaining of the site's EH&S policies that define requirements to maintain compliance with regulatory requirements and corporate EH&S standards., • Develop and implement improvements to safety systems to ensure compliance with requirements and continued improvement in EH&S performance., • Organize, lead, and participate in activities that promote employee ownership and engagement in EH&S., • Participate and support the site's 1st, 2nd, and 3rd party EH&S audit programs., • Actively participate in PHA, PSSR, MOC, RCA work processes as leader, coordinator and/or participant as needed., • Manage site incident investigation system, ensuring proper classification, thorough root cause investigations and appropriate corrective actions to prevent recurrence are implemented., • Create "one-pagers" and communicate key learnings from events at the site and from the broader company network events., • Learnings shared with on-site personnel as well as sharing with the broader company network., • Provide in-plant support to site leadership, operators, mechanics, contractors, and technical staff to ensure proper safety evaluation is performed and work is completed within requirements., • Complete routine field line walks (observe and engage) to provide recognition, coaching, collaboration, and training., • Assist in development and communication of EH&S KPls (leading/lagging) on plant dashboards., • Gather data and maintain systems to track necessary information for internal safety, health and environmental reporting and to drive improvement in EH&S performance., • Support all environmental regulatory programs such as Air Quality (Title V), Stormwater management, waste management, Community RTK, and local POTW pretreatment program., • Support and contributes to required submissions for regulatory compliance on time and in full for proper submission to regulatory authorities - Title V, Annual Emission Inventory, Tier Il, Discharge Monitoring Report, et. al., • Ensure EH&S training is effective in sharing safety know-how needed to achieve world class safe operations., • Participate and work with the site EH&S committee to accomplish EH&S objectives and to maintain continued compliance with all requirements. Provide coaching at all levels of the organization., • Assist EHS Manager with case management, working closely with site leadership and business level occupational health professionals and the offsite clinic to manage injuries to the most positive case outcomes. Ensure proper injury, illness classifications and OSHA record keeping is completed., • Maintain EH&S operating discipline. What You'll Need: Education: • Bachelor's degree in engineering, a related safety or environmental field, or equivalent industry experience is required. Experience: • Must have at least five or more years EH&S experience., • Demonstrated EH&S functional/technical expertise with strong working knowledge of OSHA regulations., • Experience with environmental regulatory filings for manufacturing operations., • Leadership skills and ability to work independently and collaboratively. Demonstrated ability to influence teams and resolve conflicts in support of organizational goals., • Excellent interpersonal skills; demonstrated ability to work effectively, professionally and respectfully in a team-based environment to involve peers, customers, line management and technical competency experts., • Experience with organizational culture change/development., • Demonstrated data management and analytical skills., • Must possess and/or demonstrate leadership competencies and behaviors (either through direct reports or project management/matrix environment)., • Hazardous waste manifesting experience or willingness to complete training;, • Demonstrated understanding and awareness of safety and environmental regulations., • Strong understanding of EHS principles and regulations., • Ability to work independently and collaboratively., • Ability to read, spell, comprehend, and perform and apply basic math skills;, • Excellent computer aptitude, communication and interpersonal skills;, • Computer skills - Email, SAP, Word Processing, Spreadsheets;, • Self-directed and self-motivated;, • Must possess strong communication and influencing skills utilizing courage and integrity;, • Good verbal and written communication skills;, • Understanding of Process Safety Management (PSM) preferred;, • Understanding of ISO 14001, ISO 45000, and ISO 50000 preferred. Work Environment • This role spends approximately 30% of the time in an office environment and 70% of the time in the plant environment. Physical Demands • While performing the duties of this job, the employee is required to speak or hear. The employee is frequently required to stand; walk, climb stairs, use hands and fingers to handle or feel; and reach with hands and arms; work in hot, cold and loud environments. Position Type/Expected Hours of Work • This is a full-time position. Days and flexible hours of work are required to meet facility demands. AAP/EEO Statement Roquette is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. "AAP, EEO, Drug-Free Workplace" Other Duties 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. If you identify yourself in this position, please apply byuploading your resume and let's start the journey together! Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences. Roquette strives to create a dynamic workforce while remaining firmly committed to equal opportunity by complying with EEO laws. As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach. To find out more about our products, values and sustainable development ambitions visit us at and at

Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients. Want to help us make a difference? Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients. Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles. We are looking for our next Plant Manager within one of our pharmaceutical excipient production facilities. The Plant Manager will be responsible for site personnel, legal compliancy of assets, community relations, and achievement of business and corporate goals. The role provides strategic direction across all site functions, supports and establishes a productive culture, and is a key member of the business operations leadership team. This position is located in Newark, DE. Compensation: The current salary range for this role is estimated to be $173,000 - $234,000. In addition, this position may also be eligible to earn performance-based incentive compensation. The specific compensation offered to a candidate will be influenced by a variety of factors including but not limited to skills, qualifications, experience, and location. What You'll Do: • Health, Safety, Environmental, Food Quality and Product Safety & Core Values, • Establishes managing processes for advancing and ensuring consistency of Core Values (HSE/PSM, Ethics & Respect for People) across the site., • Ensures regulatory compliance across all core values including product integrity and food safety., • Leads identification and prioritization of risk reduction opportunities, establishes clear priorities and supports effective resourcing to drive improvement at the site. (EHS/PSM, Site security), • Leads relationship with local authorities including safety, food safety, health regulatory agency, customs, police., • Interfaces with municipal entities and manages relationships with site service suppliers., • Ensures follow up and consistency of pharma compliance protocols and continuous improvement plans., • Maintains positive community relations through active participation in local organizations., • Accountable for leading and managing the site's Environmental, Occupational Health and Safety, Quality and Food Safety Management Systems (ISO9001:2015, FSSC 22000) requirements., • Engages all employees in HSE awareness and training, striving for zero incidents., • Leadership and Management, • Provide leadership that gives clear, consistent mission and direction in alignment with business strategy and priorities., • Establish, communicate and own clearly defined objectives, targets, and Masterplan, integrating priorities across all functions within the plant., • Identify, measure, track and ensure achievement of critical success factors., • Lead and drive cultural change and continuous improvement., • Coordinate production, maintenance, distribution, warehousing, and cost improvement initiatives in accordance with corporate guidelines., • Develop plans for efficient use of materials, machines, and employees., • Oversee Cost of Goods Sold and product quality and modifies production and inventory control programs to maintain and enhance profitable operation of business., • Operations Strategy & Planning, • Communication of business objectives, priorities and progress across the site., • Communication within Roquette off-site and above site., • Develops, implements and renews site objectives and Masterplan, including a clear site vision, which supports the Roquette strategy., • Leads site staff team in identifying Key Performance Indicators (KPI's) and aligning site Masterplan with business strategy and anticipating future needs., • Productivity, • Accountable for advancing Lean culture of continuous improvement (visual management, people, environment, site vision, empowerment, accountability, visual controls, performance dialog, structured problem solving)., • Responsible for site's infrastructure capabilities, asset integrity, improvement and resource plans via evergreen Masterplan., • Utilizes performance tracking metrics to drive execution., • Community/Industrial Relations, • Establish and maintain good working relationships with local community, civic groups, other businesses and manufacturing operations within the industrial community, and political and legislative representatives., • Maintain close liaison with first responders and regulatory agencies to ensure that company meets its obligations as a corporate citizen in the community., • Act, with the support of the HRLR function, as the primary site representative for interactions with employee representative bodies, unions, and works councils, ensuring constructive and transparent dialogue., • Proactively manage industrial relations to support a positive, collaborative labor climate while ensuring compliance with all relevant labor laws, agreements, and corporate policies., • Lead or support collective bargaining processes, negotiations, and conflict resolution, balancing business objectives with employee interests., • Monitor and address workforce concerns, grievances, and disciplinary matters with fairness, consistency, and in accordance with legal and policy requirements., • Foster open communication, mutual respect, and engagement between site leadership, employees, and their representatives., • Morale, Talent Management & Capability Building, • Develops people at the site (feedback, coaching, mentoring, delegation, difficult conversations, capability building, clear objective-setting)., • Encourages employee's engagement and fosters empowerment and ownership through leader standard work practices., • Establishes and ensures the effectiveness of two-way communication processes across the site., • Manages staffing strategy (core/ variable, overtime management and labor planning)., • Provides strategy and ensures effectiveness of the reward and recognition system across the plant., • Utilizes talent management processes and systems (succession planning, top talent, Individual Performance Plan)., • Cultivates an inclusive, respectful, and collaborative workplace, empowering employees and encouraging participation in site initiatives., • Implement strategies to attract, retain, and develop top talent, ensuring long-term organizational capability. What You'll Need: Education: • M.Sc. degree in engineering or science with experience in either industrial biochemistry, pharma or food additives; or a Bachelor's Degree in engineering with 10+ years related experience and/or training; or equivalent combination of education and experience. Experience: • Manufacturing experience which includes exposure to HSE, Quality, Food Safety/Pharma, Maintenance and Continuous Improvement systems and tools., • Experience in supervising people and leading teams., • Role model and advance Lean Behaviors, Core Values: Authenticity, Forward Looking, Well Being, Excellence, and Roquette principles of action: trust, empowerment, collaboration and accountability. Work Environment: • This role spends approximately 70% of the time in an office environment and 30% of the time in the plant environment. Physical Demands: • While performing the duties of this job, the employee is required to speak or hear. The employee is frequently required to stand; walk, climb stairs, use hands and fingers to handle or feel; and reach with hands and arms; work in hot, cold and loud environments. Position Type/Expected Hours of Work: • This is a full-time position. Days and flexible hours of work are required to meet facility demands. AAP/EEO Statement Roquette is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. "AAP, EEO, Drug-Free Workplace" Other Duties 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. If you identify yourself in this position, please apply byuploading your resume and let's start the journey together! Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences. Roquette strives to create a dynamic workforce while remaining firmly committed to equal opportunity by complying with EEO laws. As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach. To find out more about our products, values and sustainable development ambitions visit us at and at

Job DescriptionSenior Facilities TechnicianAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Senior Facilities Technician position is responsible for performing and documenting the required maintenance and monitoring of the facility, systems and equipment. The required duties include execution of Preventive and Corrective/General/Emergency maintenance on the facility’s mechanical systems and equipment, installation of new equipment and general plumbing, electrical and carpentry work, operation of the facility’s systems, including HVAC, environmental monitoring and BMS systems, and other duties as assigned. The position is required to perform the listed duties to minimize equipment downtime, support projects, and ensure that the needs of internal and external customers are met. The objective of this position is to ensure the facility is maintained in a state of maximum uptime and reliability, and provide a safe, clean and efficient environment. • Monitor and respond to equipment or facility alarms, • Travel to and support different sites when necessary., • Work with facilities, engineering and operations to ensure schedules are maintained and delays are properly communicated to customer., • Be available to work nights or weekends, on a rotating basis, to service company needs., • Maintain proper stock, parts, tools, and safety equipment., • Take orders from supervisors for maintenance and repair of systems and buildings, • Clear and clean job sites of debris and other hazardous materials and ensure that they are restored to their original states, • Assist mechanics and other technical staff in testing, cleaning and repairing utility systems, • Provide support in repairing potholes and gutters, • Assist office staff in custodial services and grounds keeping activities, • Clean and maintain floor surfaces, ceilings and windows, • Empty trash receptacles and ensure appropriate disposing off of trash, • Clean restrooms and replenish supplies, • Move equipment and furniture around the building, • Assist stock personnel in handling inventory duties along with providing support in receiving, verifying and storing office supplies, • Maintain full knowledge of the environmental monitoring system as required for monitoring equipment and troubleshooting issues as they relate to equipment and the facility Systems., • Perform all assigned PM’s and WO’s on equipment., • Document all work as performed according to cGMP’s and HCATS SOP’s., • Provide ongoing insight to Supervisors where SOP’s and PM Job Plans need to be updated. Assist Supervisors as required in the preparation of change controls or other required documentation., • Maintain cleanliness of the Facility and Maintenance areas., • Maintain 100% training records for all required training., • Provide 24-hour emergency response as required., • Perform any work required to ensure the safety of the facility and staff, including snow/ice removal as required., • Coordinate contractors, ensure contractors are properly trained and the training is documented before any work is performed., • Perform all duties in accordance with all applicable safety regulations., • Monitor overall job environmental, health and safety aspects and understands the risks and liabilities associated with various facilities maintenance and repair activities., • Must be able to recognize hazard conditions, take appropriate work place safety measures and wear appropriate personal protective equipment to suit work environment.REQUIREMENTS, • 3 to 5+ years of experience in Facility Maintenance., • Good analytical skills and attention to detail with ability to read and interpret blueprints, plans, and manuals., • Excellent customer service skills with desire to exceed customer expectations., • Ability to work independently in a timely manner, ensuring job is done correctly the first time., • Experience in a cGMP environment preferred., • Must be able to communicate clearly and effectively, both written and verbally., • Must be able to work independently and in a team environment, • Must train and become gown qualified to enter and work in classified manufacturing areas., • Valid driver’s license and clean driving record, • Must be able to pass drug test(s) as required by company, • This job may require occasional evening and weekend work.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.

Experience in pharmaceutical manufacturing or a GMP-regulated environment. Cost Analyst- Pharmaceutical Manufacturing; North America. LTS is seeking a detail-oriented Cost Analyst to support financial decision-making across manufacturing, operations, projects, and administrative functions.

GMP Sr. Auditor Paramus, NJ Experience level: Mid-senior Experience required: 5 Years Education level: Bachelors degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No Job Summary: The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes. Key Responsibilities: Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers. Prepare detailed audit plans, checklists, and schedules. Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines. Review and approve deviations, CAPAs, and change controls. Document audit observations and issue formal audit reports. Track and verify implementation of corrective and preventive actions (CAPAs). Provide guidance on compliance requirements and audit readiness. Support regulatory inspections and customer audits. Identify systemic issues and recommend process improvements. Stay updated on evolving regulatory requirements and industry best practices. Qualifications: Bachelors degree in Life Sciences, Pharmacy, or related field. 35 years in Radio Pharmaceuticals, with at least 2 years in auditing. Strong knowledge of RPT cGMP, GDP, and global regulatory requirements. Excellent attention to detail and analytical skills. Strong communication and report-writing abilities. Ability to travel (up to 10%) for audits. Preferred Certifications: ASQ Certified Quality Auditor (CQA) ISO 9001 Lead Auditor GCP/GMP auditing certifications Working Place: Paramus, New Jersey, United States Company: ESR Healthcare

Experience level: Mid-senior Experience required: 5 Years Education level: Bachelors degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Companys compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. 5+ years of pharmaceutical experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required Paramus, NJ, United States ESR Healthcare

Job Description Title: QC Chemist II Location: NJ5-Totowa, New Jersey Department: Radiopharmaceutical Contract Manufacturing Training Curriculum ID: TCU.004 Overview The QC Chemist II will perform analysis of diagnostic and therapeutic radiopharmaceuticals for SOFIE within the Radiopharmaceutical Contract Manufacturing Division. Following SOFIE’s QA program and cGMP guidelines, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and EudraLex Volume 4). Essential Duties And Responsibilities Conduct required Quality Control analytical tests for regular production of radiopharmaceuticals for preclinical, clinical, or commercial use according to cGMP standards. Prepare standards, samples, and mobile phase solutions for analytical methods. Perform precise visual inspection or laboratory appearance testing of finished product, requiring 20/20 vision and accurate color differentiation, to assess product quality by evaluating color, clarity, and absence of visible particulates for the drug product solution and evaluating attributes of the container closure system (e.g., cracks or chips in glass vials, creases in crimps, presence of stoppers, color of flip tops), in compliance with FDA, EudraLex and Rest of World guidance. Initiate deviation and OOS reports, lead root cause investigations. Assist in development, implementation, and validation of Quality Control analytical methods. Follow protocols for the analysis of clinical-grade radiopharmaceuticals, validate these methodologies against quality requirements, and implement them for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards. Validate existing analytical methods on existing or new equipment; follow method transfer protocols for clinical and commercial-grade radiopharmaceuticals. Write clear Standard Operating Protocols (SOPs) for QC protocols. Review existing SOPs and suggest logical modifications based on scientific rationales and/or regulatory requirements. Install, qualify, and maintain laboratory equipment on site. Collaborate with production radiochemists as required to ensure successful protocol development and radiopharmaceutical production. Perform release testing, according to SOPs, on other materials (e.g., raw materials for radiopharmaceutical production). Conduct environmental monitoring of environment and facilities. Maintain all qualification and validation requirements for entering ISO classified areas. Maintain a clean and safe working environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations. Maintain accurate radiopharmaceutical test and validation results. Liaise with contract partners as needed (e.g., biotech and pharma). Other duties as assigned. Qualifications Bachelor’s degree in Chemistry or natural science required with 2+ years of experience in analytical chemistry and instrumentation (qualification, troubleshooting and maintenance); a Master’s degree preferred. Experience in a GMP manufacturing environment is highly preferred. Expertise in laboratory procedures and analytical chemistry techniques required (thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.). Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification required. Efficient in the use of MS Office Suite; detail-oriented, accountable, patient, organized, and able to work in a team environment with minimum supervision. Strong Technical Writing Skills required. Excellent organizational skills required. 20/20 natural or corrected vision and normal color vision for the performance of visual inspection or appearance testing. Ability to work various shifts and weekends required. #J-18808-Ljbffr

The Category Manager for Chemical category is responsible for defining and executing category strategies across key chemical segments (e.g., actives, surfactants, alcohols, extracts etc), driving cost optimization, supply resilience, and long-term value creation. This role combines strategic leadership with strong analytical and commercial capabilities, ensuring alignment with business priorities while managing supplier partnerships and risk across assigned categories. The Category Manager leads end-to-end sourcing initiatives, leverages data-driven insights, and collaborates cross-functionally to deliver sustainable results and continuous improvement. • Develop and implement chemical category strategies aligned with business objectives, • Manage full category lifecycle including supplier segmentation and risk mitigation, • Identify and execute value creation opportunities, • Monitor market trends and adapt strategies proactively, • Lead complex sourcing initiatives (RFx), • Negotiate commercial agreements including pricing and terms, • Manage supplier relationships and performance, • Drive supplier innovation and continuous improvement, • Analyze spending, market intelligence, and supplier performance data to support decision-making, • Develop category dashboards and KPIs to track performance against targets, • Leverage data insights to identify trends, risks, and optimization opportunities, • Ensure accuracy and integrity of category and supplier data, • Maintain accurate and up-to-date data in procurement trackers to support financial reporting and ensure alignment with Finance requirements, • Act as the primary escalation point for supply issues related to managed suppliers, ensuring timely resolution and minimal operational disruption, • Support sites in local negotiations, providing guidance and alignment with category strategies and commercial frameworks, • Collaborate with local teams to ensure adherence to preferred suppliers and sourcing strategies while addressing site-specific needs, • Provide expertise and support on supply continuity, risk mitigation, and alternative sourcing when required, • Partner with cross-functional teams, • Act as procurement lead for assigned categories, • Influence stakeholders and drive adoption, • Ensure compliance with policies and contracts, • Manage supply risk and contingency plans, • Support audit requirements, • Strong strategic thinking and category management expertise, • Advanced negotiation and commercial acumen, • Strong analytical and data-driven decision-making skills, • Stakeholder influence and leadership across functions, • Supplier relationship management and partnership mindset, • Self-driven; leads and influences without authority, • Problem-solving and continuous improvement orientation, • Ability to balance strategic initiatives with operational priorities 812 years of experience in direct procurement or category management, preferably in chemical categories such as actives, surfactants, alcohols, and extracts etc. A bachelor's degree in business or a related field is required. Experience in pharmaceutical, personal care, home care, beauty industry, or chemical manufacturing environment is strongly preferred. Experience in co-manufacturing and decentralized organizations is an asset.

Job DescriptionProvides administrative and secretarial support for the vice president and department. RESPONSIBILITIES • Monitors and oversees facility operations for a large biotech site., • Troubleshoots and performs repairs on system issues involving electronic, electrical, pneumatic, hydraulic, and mechanical devices, Johnson Controls Metasys BMS, utility, and water systems., • Supervisor in charge of facility housekeeping staff for second shift., • Generates work orders in SAP, participates in site emergency response and Hazmat activities. Novartis Pharmaceuticals 01 Sep 2005 - 01 May 2014 ENGINEERING TECHNICIAN 1216 5th Avenue New York NY , 10029 OK to contact this employer? - No RESPONSIBILITIES • Repaired, maintained, and calibrated pharmaceutical manufacturing, production and packaging equipment., • Experienced with calibrations, instrumentation, process control systems, Honeywell, Andover, DDC/BMS HVAC systems, USP water systems, Werum Object Management CMMS. • Automation skills in PLCs; Allen Bradley PLC 5, SLC 500, Logix 5000, MicroLogix, CompactLogix, etc. PLCs and PowerFlex drives. • Familiar with pharmaceutical procedures, cGMPs, FDA regulated, clean zone work environments.

A leading CDMO is seeking a skilled Pharmaceutical Technician for their 2nd shift in Somerset, New Jersey. This role involves dispensing, milling, blending, and other manufacturing processes in a fast-paced environment. Candidates should have a High School Diploma and some experience in a regulated

Compliance with cGMP (current Manufacturing Practices) and all Company SOP's (Standard Operating Procedures). Supply Production Floor and/or Manufacturing department with required components, raw materials, and bulk inventory per required production schedule.