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

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 DescriptionJob Title: QC Microbiology Compliance Investigator Job Description As a QC Microbiology Compliance Investigator, you will play a pivotal role in determining the causes and preventative actions of Deviations, Non-Conformances, Out of Specifications (OOS), Out of Trends (OOT), and environmental excursion investigations. You will drive investigations to their true root cause using appropriate tools, benchmark industry standards, and implement investigative and impact assessment toolsets. Your work will define and implement effective preventative actions to prevent recurrence while managing multiple investigations efficiently. Responsibilities • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approaches., • Develop materials to train personnel on writing problem statements and using root cause analysis tools., • Manage CAPA plans and their implementation., • Communicate plans for ongoing deviations and CAPAs effectively., • Oversee the timely completion of deviations, CAPAs, and Change Controls., • Expertise in laboratory processes, CAPA, Bioburden, and Aseptic techniques., • Experience in investigations and analysis, including life-cycle investigations of deviations and non-conformances., • GMP Training, Quality Systems Training, and Safety Training., • Experience with QC Micro deviations and compliance in microbiology., • Bachelor of Science in a Quality/Process-related field or equivalent experience., • 3-5 years of experience in quality control or assurance within the bio-pharma, biologics, or pharmaceutical industry., • Experience leading event investigations, Root Cause Analysis (RCA), and CAPA., • Technical experience in writing and assessing deviations, investigations, and OOS., • Strong IT skills, including proficiency with Visio, Microsoft Project, and Excel. You will work in a GMP Commercial Facility with a schedule of Monday to Friday on the 1st shift. Flexibility is essential. The work environment offers a great atmosphere, opportunities for growth, and the chance to be part of a new project taking a client's product commercial. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. This position is urgently hiring - If interested, please submit your updated resume along with your availability for a 5-minute call to kvespia @astoncarter.com Pay and Benefits The pay range for this position is $45.55 - $45.55/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Oct 20, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Job Description Summary The Commercial Counsel - Customer Contracts provides timely legal counsel on commercial matters including contract management matters for the U.S. Sterile Injectable and Generics business unit. This Attorney will strategically and efficiently lead, coordinate, facilitate and manage contract requests across these two business segments, which shall include the preparation and negotiation of commercial agreements including numerous customer agreements. The role will manage adherence to the Endo contract management process, including utilization of the Legal Department’s contract management tool. In addition to providing contract support, the position will provide commercial and regulatory counsel and support on commercial initiatives and promotional labeling through the MARC review process. All incumbents are responsible for following applicable Division & Company policies and procedures. Job Description Accountability Responsibilities % of Time Contract Management • Independently consult, advise, and represent the Company on a variety of highly complex contractual legal matters, particularly customer agreements, for the sterile injectable and generics and business units., • Act as advisor of commercial contract management processes, with strong project management skills, legal analysis, quality standards, and strong understanding of contract terms based on client need and business objectives., • Provide legal advice and counsel to business colleagues to assist the Company in managing risk with respect to contract-related matters Business Unit Counsel • Provides legal advice and counsel to business colleagues in the Sterile Injectables and Generics Business Unit to assist the Company in managing risk with respect to regulatory compliance of commercial initiatives and promotional labeling through the Company’s MARC review process for the sterile injectable and generics business units. Special Projects • Assist with development and or creation of policies, standards, and procedures for contract management., • Assist with other special projects as assigned, • Juris Doctor degree from an accredited law school required., • Bar admission in New Jersey and Pennsylvania preferred., • Minimum eight years senior level experience with customer contracting at law firms, corporate legal departments, or other service providers required., • Previous attorney position at law firm, corporate legal department or other relevant service provider., • A deep understanding of pharmaceutical contracting across various commercial business segments, including generics, government and hospital-based contracts as well as corporate support areas (e.g., Finance, IT, etc.)., • Understanding of laws and regulations applicable to pharmaceutical marketing and commercialization for the sterile injectable and generics business units., • Understanding of contracts management programs and requirements., • Demonstrated success in the management of multiple projects ranging in size and scope, with an emphasis on larger more complicated matters., • Ability to operate independently while providing legal counsel and guidance in fast paced fluctuating environment., • Good research skills with an ability to analyze and interpret complex information., • Strong written and negotiation skills., • Effective verbal and written communication skills supporting interaction with various levels of employees and management (e.g. diplomacy, advocacy and “active” listening skills)., • Excellent client relationship skills, which include the ability to proactively manage client expectations., • Excellent judgment and ability to make concrete recommendations., • Leadership abilities coupled with strong personal accountability and initiative., • Ability to multitask under pressure., • Excellent organizational, planning, prioritization and problem-solving skills., • Customer service demeanor; approachable, respectful and polite., • Ability to build and maintain effective working relationships, both within the Company and with outside suppliers., • Superior technical communication skills., • Flexibility in unanticipated situations., • Ability to own tasks from start to finish with limited supervision., • Expert level PC user with deep familiarity utilizing Microsoft Office Suite. EEO Statement: We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

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

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 Title: Investigation and Deviation Writer Job Description We are seeking a dedicated Investigation and Deviation Writer responsible for writing and completing investigations and deviations from a compliance and operations perspective. This role involves conducting root cause analyses and managing the full lifecycle of investigations, from initiation to closure, to ensure manufacturing and GMP compliance. Responsibilities • Determine the causes and preventative actions of Deviations, Non-Conformances, Out-of-Specification (OOS), Out-of-Trend (OOT), field complaints, and environmental excursion investigations., • Drive investigations to uncover true root causes using appropriate tools and benchmark industry standards., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track Corrective and Preventative Action (CAPA) plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Utilize change management approaches effectively., • Develop training materials to educate personnel on writing problem statements and using root cause analysis tools., • Champion CAPA plans and implementation., • Provide ongoing communication plans for deviations and CAPAs., • Oversee timely completion of deviations, CAPAs, and Change Controls., • Ensure adherence to quality standards.Essential Skills, • 2-3 years of experience writing and reviewing deviations and investigations within a pharmaceutical company., • Experience working with quality assurance teams to ensure accurate tracking and documentation of investigations., • Proficiency in root cause analysis, CAPA, and biologics., • Experience with GMP operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma., • Familiarity with e-Quality Management Systems.Additional Skills & Qualifications, • Bachelor's degree in a related scientific field., • Experience in technical writing., • Experience with cell and gene therapies or biologics., • Relevant IT skills, including proficiency with Visio, Microsoft Project, and Excel.Work Environment You will work closely with a team of QA/QC professionals in a collaborative environment, engaging cross-functionally with the manufacturing team. The role involves working at two sites located close to each other. The team consists of five other investigators, and you will work the first shift from Monday through Friday, starting between 8 AM and 9 AM. The company offers a supportive work culture with opportunities for growth and expansion, as well as the satisfaction of contributing to saving patients' lives. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. Pay and Benefits The pay range for this position is $40.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Oct 20, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

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

Job Description Clinical Supplies Manager needs Bachelors degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background Clinical Supplies Manager requires: CDMO management, Master Batch Records (MBR), Master Packaging Work Orders (MPWO), Interactive Response Technology (IRT), Interactive Web Response System (IWRS), Excel, Microsoft Office, ARIBA, Clinical Trial Material (CTM) inventory forecasting, regulatory submissions (IND, Annual reports, amendments), SOP writing, SOP review, study protocols, pharmaceutical stability protocols, GMP batch record development/review/approval, GCP, cGMP, supply chain management, budget management, financial tracking, RFP preparationve, Bachelors degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background. Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals. Also, should be able to interpret financial reports. Expert technical skills, good organization skills, ability to follow directions, and good communication skills. Computer aptitude is a plus, especially proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data. Understand protocols, write SOPs, and have technical knowledge of packaging and labeling activities. Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products Knowledge of GMP batch record development, review, and approval process Demonstrated understanding of the entire supply chain and associated cost drivers Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system. Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus. Knowledge of warehousing, distribution (including cold chain distribution), and logistics, a plus. Ability to review, analyze, and interpret the IVR/IRT reports and specification requirements, a plus. Ability to understand, maintain, and demonstrate troubleshooting on vendors IRT/IVRS system, a plus. Clinical Supplies Manager duties o Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies. o Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents. o Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product. o Assist and support the management of clinical supply inventories using Interactive Response Technology. o Expected to prepare data tables when needed for data interpretation. o Assist with documentation and process internal and external change controls. o Assist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc. o Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking. o Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global). o Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits. o Assist and support Clinical Operations on document reviews related to o o Assist collaborated team to prepare clinical supplies request forms for new and existing studies when its need it. o Prepare requests for proposals for activities in support of clinical supply projects. o Review CDMO Project proposals and provide feedback to the Associate Director before selecting a specific vendor, review and audit slides, tables, and budget calculations. o Assist and prepare CDMO Vendor Comparison slides and assist in the selection of an appropriate CDMO based on technical ability, cost, and ability to deliver on time. o Provide technical support for vendors IRT/IWRS system in support of SK clinical studies. o Utilize inventory forecasting software to ensure an adequate amount of CTMs is available to supply clinical sites when needed. o Assist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments. o Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols. o Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc. o Assist and prepare Excel tables when needed. o Assist in the maintenance of SOPs related to reflecting current clinical supply activities. o Assist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors. o Financial Management o Prepare Ariba process for internal budget approval of new/ongoing CMC Team projects. o Prepare, maintain, and monitor project budgets for the CMC Team o Review and process clinical supply CMO invoices for project activities. o Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested. o Participate in project budgeting and forecasting process for the CMC Teams annual project o

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

Job Description Clinical Supplies Manager Paramus, NJ Clinical Supplies Manager Paramus, NJ Experience level: Mid-senior Experience required: 8 Years Education level: Bachelors degree Job function: Management Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No SUMMARY OF POSITION: Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies. Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents. Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product. Assist and support the management of clinical supply inventories using Interactive Response Technology. Expected to prepare data tables when needed for data interpretation. Assist with documentation and process internal and external change controls. Assist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc. Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking. Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global). Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits. Assist and support Clinical Operations on document reviews related to KEY RESPONSIBILITIES: Technical Management Assist collaborated team to prepare clinical supplies request forms for new and existing studies when its need it. Prepare requests for proposals for activities in support of clinical supply projects. Review CDMO Project proposals and provide feedback to the Associate Director before selecting a specific vendor, review and audit slides, tables, and budget calculations. Assist and prepare CDMO Vendor Comparison slides and assist in the selection of an appropriate CDMO based on technical ability, cost, and ability to deliver on time. Provide technical support for vendors IRT/IWRS system in support of SK clinical studies. Utilize inventory forecasting software to ensure an adequate amount of CTMs is available to supply clinical sites when needed. Assist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments. Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols. Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc. Assist and prepare Excel tables when needed. Assist in the maintenance of SOPs related to reflecting current clinical supply activities. Assist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors. Financial Management Prepare Ariba process for internal budget approval of new/ongoing CMC Team projects. Prepare, maintain, and monitor project budgets for the CMC Team Review and process clinical supply CMO invoices for project activities. Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested. Participate in project budgeting and forecasting process for the CMC Teams annual project budget management activities. QUALIFICATIONS: Bachelors degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background. Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals. Also, should be able to interpret financial reports. Expert technical skills, good organization skills, ability to follow directions, and good communication skills. Computer aptitude is a plus, especially proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data. Understand protocols, write SOPs, and have technical knowledge of packaging and labeling activities. Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products Knowledge of GMP batch record development, review, and approval process Demonstrated understanding of the entire supply chain and associated cost drivers Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system. Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus. Knowledge of warehousing, distribution (including cold chain distribution), and logistics, a plus. Ability to review, analyze, and interpret the IVR/IRT reports and specification requirements, a plus. Ability to understand, maintain, and demonstrate troubleshooting on vendors IRT/IVRS system, a plus.

Job DescriptionJob Title: QA InvestigatorJob Description We are seeking a dedicated QA Investigator to join our team. The role involves writing and completing investigations and deviations, ensuring compliance from both compliance and operations perspectives. The ideal candidate will conduct root cause analysis and manage the entire lifecycle of investigations independently, communicating effectively with vendors and manufacturing teams. Responsibilities • Determine the causes and preventative actions of Deviations, Non-Conformances, Out of Specification (OOS), Out of Trend (OOT), field complaints, and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools and benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track Corrective and Preventive Action (CAPA) plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approaches., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy, and deviation processes., • Champion CAPA plans and implementation., • Provide communication plans for ongoing deviations and CAPAs., • Create and communicate CAPA plans effectively to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • 2-3 years of experience writing and reviewing deviations and investigations., • Experience within a pharma company supporting manufacturing., • Previous experience within a quality assurance team., • Bachelors degree within a related scientific field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operations., • Experience using e-Quality Management Systems., • Experience with CAPA and GMP., • Knowledge of biopharma/biotech and biologics., • Technical writing skills. The QA Investigator will work closely with quality assurance and a team of QA/QC professionals on a daily basis, collaborating cross-functionally with the manufacturing team. The role is based at two sites located a block apart, and the team currently includes five other investigators. The position operates on a first-shift schedule from Monday through Friday, with start times at either 8 am or 9 am. The company offers a supportive work culture with opportunities for growth and expansion, focused on saving patients' lives. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. Pay and Benefits The pay range for this position is $40.00 - $46.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Oct 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

The Commercial Counsel - Customer Contracts provides timely legal counsel on commercial matters including contract management matters for the U. A deep understanding of pharmaceutical contracting across various commercial business segments, including generics, government and hospital-based contracts

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