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Job Details

All Jobs / Req# 37660
Req Number:
37660
Req Title:
Senior Specialist Quality Assurance - Level III
Client:
A Major Pharma Company
Work Address:
Durham, NC
Req Release Date:
10/01/2025
Duration:
6 months
Hours a week:
40 Hours
Position Summary

Responsibilities:

Responsibilities to include but not limited to the following:

  • Batch record review/approval.
  • Technical protocol review/approval.
  • Equipment qualification protocol review/approval.
  • Deviation review/approval.
  • Execute shop floor quality audits.
Qualifications:
  • Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry.
  • Would consider Associates w/good relevant experience.
  • Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer.
  • Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.
  • Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills.
  • Must have very strong relationship building skills.
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