Quality Assurance Associate
hace 4 días
Plainfield
Job DescriptionJob Title: Quality Assurance Associate Job Description We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to support our cell therapy operations. This role involves maintaining and improving the Quality Management System (QMS), with a focus on managing CAPAs, deviations, and investigations. The ideal candidate will have experience in GMP environments and a strong understanding of regulatory requirements for advanced therapy medicinal products (ATMPs). Responsibilities • Lead and manage the CAPA process, ensuring timely and effective root cause analysis, action implementation, and verification of effectiveness., • Oversee deviation management, including intake, triage, investigation, and closure., • Conduct and support investigations related to product quality, process deviations, and non-conformances., • Collaborate with cross-functional teams (Manufacturing, QC, MS&T, etc.) to ensure robust documentation and resolution of quality events., • Maintain and continuously improve QMS elements such as document control, change control, training, and audit readiness., • Support internal and external audits, including regulatory inspections., • Analyze quality data and metrics to identify trends and areas for improvement., • Ensure compliance with FDA, EMA, and other applicable regulatory standards for cell therapy products., • Author and review SOPs, work instructions, and quality documentation., • Provide QA oversight for manufacturing and laboratory operations.Essential Skills, • Bachelor's degree in life sciences, engineering, or related field; advanced degree preferred., • 3+ years of experience in Quality Assurance within a GMP-regulated environment, preferably in cell therapy, biologics, or pharmaceuticals., • Strong knowledge of QMS principles and regulatory requirements (21 CFR Part 11, Part 210/211, EU GMP, ICH guidelines)., • Experience with CAPA, deviation, and investigation systems., • Excellent communication, organizational, and problem-solving skills., • Proficiency in electronic QMS platforms (e.g., Veeva, MasterControl, TrackWise)., • Ability to work independently and collaboratively in a fast-paced environment.Additional Skills & Qualifications, • Experience in cell therapy or ATMP manufacturing., • Familiarity with aseptic processing and cleanroom operations., • Six Sigma or Lean certification is a plus., • 5–7 years of QA experience in a GMP-regulated environment, ideally with cell therapy, gene therapy, or other advanced biologics; CDMO experience strongly preferred., • Strong knowledge of batch record review, aseptic operations, and environmental monitoring and cGMP regulations (21 CFR Parts 210, 211, 1271), and relevant ICH and FDA guidance., • Demonstrated ability to lead and close complex quality investigations, including root cause analysis and development of effective CAPAs., • Proficient in investigation tools and methodologies such as Fishbone diagrams, 5 Whys, FMEA, and other risk-based quality tools., • Willingness to work in ISO 7 environments for on-the-floor QA support., • Proactive, adaptable, and committed to continuous learning., • Flexibility to travel between facilities and work varying hours, including evenings, weekends, and shifts as needed.Work Environment This position is located at a growing CDMO in the field of Cell/Gene Therapy at a brand new site. The work environment involves working in ISO 7 conditions for on-the-floor QA support and requires flexibility in working hours, including evenings, weekends, and shifts as needed. It offers an opportunity to be part of a team in a dynamic and innovative setting focused on operational excellence and continuous improvement. Job Type & Location This is a Contract to Hire position based out of NA, New Jersey. Pay and Benefits The pay range for this position is $25.00 - $35.00/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 Plainfield,NJ. Application Deadline This position is anticipated to close on Sep 23, 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.
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