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Senior Specialist Quality Assurance III at Spectraforce Technologies
Spectraforce Technologies
Durham, North Carolina
Finance
Posted 0 days ago
Job Description
Senior Specialist Quality Assurance III
Durham, NC 27712
12 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:
* Batch record review/approval
* Technical protocol review/approval
* Equipment qualification protocol review/approval
* Deviation review/approval
* Execute shop floor quality audits![]()
Durham, NC 27712
12 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:
* Batch record review/approval
* Technical protocol review/approval
* Equipment qualification protocol review/approval
* Deviation review/approval
* Execute shop floor quality audits
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