Pharmaceutical QA Senior Specialist Group Leader

This position provides Quality Assurance oversight for Quality Control (QC). Provide QA (Quality Assurance) review and approval of Quality method validation/ QC equipment qualification QC protocol reports QC process control document new and existing procedures and Quality Control deviation/investigations. Supports process improvements implementation. This role is in Sanford NC.

POSITION RESPONSIBILITIES:

• Perform QA technical review for assigned areas such as Validation documents Method transfer Protocol amongst others.
• Provide final QA approval on simple change control effectiveness check CAPA implementations compendial assessments and other documents associated with the business unit.
• May also review and approve documents such as Deviation complaints investigations Laboratory 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.
• Capable to Make quality decisions in real time according to regulations and procedures. 
• Ability to work collaboratively with internal partners to resolve technical issues.
• Willing to perform other duties as assigned and take ownership to support the implementation of activities needed for the start-up.

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

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