Quality Assurance Specialist

Job Description

We are seeking a motivated and detail‑oriented Quality Assurance Specialist to support day‑to‑day quality operations and ensure compliance across our manufacturing processes. This role provides hands‑on QA support on the production floor, assists with document control activities, and works closely with Manufacturing, Warehouse, and Quality Control teams to maintain high standards of product quality and cGMP compliance. The ideal candidate is proactive, organized, and enjoys working in a fast‑paced, mission‑driven environment.

This position offers an excellent opportunity to gain well‑rounded experience across quality operations, documentation, and floor oversight—particularly within advanced therapeutic manufacturing.

• Provide QA support for daily manufacturing operations in accordance with approved SOPs and cGxP requirements.
• Assist in reviewing executed batch records, logbooks, and production documentation for accuracy, completeness, and cGMP compliance.
• Support deviation initiation and investigation activities, including documentation, root cause analysis, and timely closure.
• Assist with material release.
• Perform routine QA walkthroughs on the manufacturing floor and escape quality events per established procedures.
• Support document control activities, including the review and routing of SOPs.
• Participate in change control processes for operational and documentation changes.
• Support quality oversight of product status, including shipping documentation and release readiness.
• Identify and help correct non‑compliance with cGMP and GDP requirements.
• Perform other QA‑related duties as assigned to support operational needs.

• Bachelor’s degree in a related field (e.g., Life Sciences, Engineering, Quality Assurance, etc.).
• 1‑5 years' experience in quality management or quality assurance, preferably in a regulated industry (e.g., medical devices, pharmaceuticals, cell & gene therapy, etc.).
• Basic understanding of cGMP principles and regulatory requirements (FDA, EMA, ICH).
• Familiarity with quality management systems and GDP practices in a GMP facility.
• Excellent communication, organizational, and analytical skills in a fast‑paced, dynamic environment.
• Ability to work both independently and collaboratively with cross‑functional teams.
• Self‑awareness, integrity, authenticity, and a growth/entrepreneurial mindset.

• Experience in cell therapy or cell‑based manufacturing is a plus.
• Familiarity with Track Wise Digital electronic QMS, Lab Vantage and SAP.

The role is based in Bridgewater, NJ, and requires working closely with cross‑functional teams and adherence to GMP facility standards. It is a fully onsite contract position.

Hourly rate: $38.00–$40.00 per hour.

Benefits may include:
Medical, dental & vision;
Critical Illness, Accident and Hospital; 401(k) Retirement Plan (Pre‑tax and Roth post‑tax contributions);
Life Insurance;
Short and long‑term disability;
Health Spending Account (HSA);
Transportation benefits;
Employee Assistance Program;
Time Off/Leave (PTO, Vacation or Sick Leave). Eligibility applies to some benefits and may depend on classification and length of employment.

This position is anticipated to close on Jun 19, 2026.

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 due to a disability, please email actalentaccom