Pharmaceutical QAQC Senior Specialist

This role will provide Quality Assurance oversight for Quality Control activities including review and approval of method validations equipment qualifications protocols reports procedures and deviations. The role supports implementation of process improvements. This is on-site in Sanford NC

• Conduct QA reviews and approvals for validation documents method transfer protocols change controls CAPAs compendial assessments and related records
• Review deviations investigations (OOS/OOT/OOE) and other Quality Events/Lab Events Electronic build of Master Batch or any electronic record when needed and all associated to compendial changes
• Make real-time quality decisions per regulations collaborate cross-functionally to resolve technical issues and support start-up activities as assigned

Qualifications :

• Bachelors or Masters Degree in relatable field (Microbiology Chemistry Pharmaceuticals etc.)
  • Bachelors degree and 6-8 years of experience 
  • Masters degree and 4-6 years of experience 
    • Relevant experience includes:
      • Manufacturing laboratory quality technical or engineering experience within biotech of the pharmaceutical industry 
      • Experience in a Quality Control Laboratory and cGMP Laboratory environment.
      • Familiarization with Pharmacopeia requirements. (e.g. USP JP EMEA amongst others.
      • Familiarization with the Data Integrity requirements.
      • Deviations Change Controls Stability Protocols and all the implementation activities. Support in CAPA closures Effectiveness checks and experience in Root Cause Analysis tools.
      • Experience in a quality assurance role preferably in Quality Assurance for a Quality Control role in the document such as: (e.g. OOS (Out of Specification) OOE (Out of Expectation) OOT (Out of Trend) investigation specification method transfer protocol stability protocol and others).
    • Proven ability to work in a team environment through conflict resolution and negotiation.
    • Valid drivers license and personal transportation
    • Authorization to work in the United States indefinitely without restrictions or sponsorship.

Additional Information :

Positions are full-time Monday - Friday 8am - 5 pm with overtime as needed.  Candidates currently living within a commutable distance of Sanford NC are encouraged to apply. 

What we offer:

• Excellent full time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Yearly goal-based bonus & eligibility for merit-based increases

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time