Senior Specialist Quality Assurance III

Senior Specialist Quality Assurance III

Durham, NC 27712

6 months

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.

Responsibilities :

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 :

Comments / Special Instructions

familiar w / SAP. PAS-X, Manufacturing Execution System would be a plus, familiar with SAP a plus These positions are more traditional Quality Assurance type stuff as the project has moved past most of the qualification stages...