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Senior Specialist Quality Assurance - Level II

Senior Specialist Quality Assurance - Level II

Careers Integrated Resources IncDurham, NC, US
3 days ago
Job type
  • Full-time
Job description

Title : Senior Specialist Quality Assurance - Level II

Location : Durham, NC

Duration : 6-months

Shift : Standard Shift

Job Description :

  • 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.
  • Responsibilities to include but not limited to the following :
  • Batch record review / approval
  • Technical protocol review / approval
  • Execute shop floor quality audits

Qualification :

  • Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 2 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.
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    Senior Quality Assurance Specialist • Durham, NC, US

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