Quality Assurance Specialist

Job Summary

Under minimal supervision, the Quality Assurance Specialist III will ensure systems and processes comply with internal, regulatory, and industry standards. He/she promotes a culture of quality and routinely reports on the performance of the Quality System to senior leadership. Candidates identify CAPAs, deviations, investigations, change controls, process improvements, and root‑cause analysis, and participate in internal and external audits.

• Participate in all aspects of quality assurance to ensure regulatory activities comply with internal procedures and external cGXP/ISO requirements.
• Maintain the internal auditing program, Management Review process, and laboratory proficiency testing program.
• Plan, prepare, host customer and regulatory audits; respond to audit reports and implement resolution of audit findings.
• Collect, track, and analyze quality metrics (OOS, deviations, complaints, etc.) and train laboratory personnel to reduce quality events.
• Monitor laboratory compliance with respect to laboratory cleanliness, training records, and ISO/GMP‑related items.
• Support quality‑event investigations using formal root‑cause analysis tools.
• Provide periodic summaries of audit outcomes and risk statements identifying uncontrolled risks within the QMS.
• Maintain the list of approved suppliers and subcontractors and audit related documents.
• Audit various reports prior to issuance and serve as site contact for quality inquiries on analytical reports.
• Audit methods, work instructions, deviations, investigations, corrective/preventive actions, risk assessments, and instrument qualification/calibration paperwork.
• Maintain site‑specific procedures including the Quality Manual, SOPs, and other QA documents.
• Create, revise, review, and approve new documents and document revisions.
• Work with Operations Management to maintain the training program ensuring laboratory personnel have completed required training.
• Train laboratory personnel in GXP/ISO procedures, practices, and guidelines.
• Serve as backup for all other QA personnel.

• Bachelor’s degree or higher in a scientific field (chemistry, biology, or life science).

• 3–5 years of experience in QA within a laboratory or regulated industry (pharmaceuticals, biotechnology, medical devices).
• Experience working in a GMP facility.
• ISO 17025:2017 accredited lab experience preferred.
• Moderate understanding of microbiology/chemistry testing.
• Understanding of USP/EP/JP standards and guidelines.
• Understanding of FDA, ISO, GLP, GMP regulations.
• Experience testing pharmaceutical, cosmetic, and/or medical device products.

• Detail‑oriented, self‑initiating with strong interpersonal written and oral communication skills.
• Strong organizational skills and ability to multitask in a dynamic, fast‑paced environment.
• Displays sound judgment, quality focus, and excellent implementation and follow‑up skills.
• Hands‑on experience and strong understanding of industry regulations (21 CFR Part 11, 21 CFR Part 820, ISO 17025, USP, GxP).
• Hands‑on experience with CAPA, change control, quality events, and validation documentation (IQ/OQ/PQ).
• Strong problem‑solving skills including root‑cause analysis using formal RCA tools (Ishikawa, 5 Ys).

• Full‑time, Monday–Friday 8:00 am–5:00 pm; overtime as needed.
• Location:
  
  North Brunswick Township, NJ (commutable distance required).
• Compensation: $60,000–$78,000 per year.
• Benefits: comprehensive medical, dental, vision coverage; life & disability insurance; 401(k) with company match; paid vacation and holidays.

We reserve the right to close or extend the position. Apply early due to high volume. Applicants not receiving a response within 4 weeks of the vacancy expiry date will not be contacted further.

Eurofins is an Equal Employment Opportunity and affirmative action employer for disabled and veteran applicants.