Eurofins Scientific is hiring a Pharmaceutical QA/QC Senior Specialist to ensure quality assurance oversight for our Quality Control operations. This on-site role at our Sanford, NC location involves reviewing and approving critical documentation, supporting process improvements, and making real-time quality decisions in a cGMP laboratory environment.
What You'll Do
- Conduct QA reviews and approvals for validation documents, method transfer protocols, change controls, CAPAs, and compendial assessments.
- Review deviations, investigations (OOS/OOT/OOE), other quality events, electronic batch records, and records related to compendial changes.
- Make real-time quality decisions in accordance with regulations, collaborate cross-functionally to resolve technical issues, and support start-up activities as assigned.
What We're Looking For
- A Bachelor's or Master's degree in a relatable field such as Microbiology, Chemistry, or Pharmaceuticals.
- 6-8 years of experience with a Bachelor's degree OR 4-6 years of experience with a Master's degree.
- Manufacturing, laboratory, quality, technical, or engineering experience within the biotech or pharmaceutical industry.
- Direct experience in a Quality Control Laboratory and cGMP laboratory environment.
- A valid driver's license, personal transportation, and authorization to work in the United States indefinitely without restrictions.
Nice to Have
- Familiarity with Pharmacopeia requirements (e.g., USP, JP, EMEA).
- Familiarity with Data Integrity requirements.
- Experience with Deviations, Change Controls, Stability Protocols, and implementation activities.
- Support in CAPA closures, Effectiveness checks, and experience with Root Cause Analysis tools.
- Experience in a quality assurance role, preferably supporting QC with documents like OOS/OOE/OOT investigations, specifications, method transfer protocols, and stability protocols.
- Proven ability to work in a team environment through conflict resolution and negotiation.
Benefits & Compensation
- Excellent full-time benefits including comprehensive medical, dental, and vision coverage.
- Life and disability insurance.
- 401(k) plan with company match.
- Paid vacation and holidays.
- Yearly goal-based bonus and eligibility for merit-based increases.
Work Mode
This is an on-site position based in Sanford, NC.
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
