Senior Specialist Quality Assurance - Level II
Careers Integrated Resources IncDurham, NC, USjob_description.job_card.variable_days_ago
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job_description.job_card.job_descriptionQuality 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.
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 :
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Senior Quality Assurance Specialist • Durham, NC, US