Senior Specialist Quality Assurance - III

Job Title: Senior Specialist Quality Assurance - III
Job Location: Durham, NC
Job Duration: 12 Months (possibility of extension)

Responsibilities:

• Batch record review/approval.
• Technical protocol review/approval.
• Equipment qualification protocol review/approval.
• Deviation review/approval.
• Execute shop floor quality audits.

Education and Experience:

• Quality Assurance professional with at a minimum a BS in 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.
• Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.

Skills and Competencies:

• Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills.
• Must have very strong relationship building skills.
• 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.