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Senior Specialist Quality Assurance - Level II

Careers Integrated Resources Inc Durham, NC (Onsite) Contractor


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

Quals--
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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Job Snapshot

Employee Type

Contractor

Location

Durham, NC (Onsite)

Job Type

QA - Quality Control

Experience

Not Specified

Date Posted

09/30/2025

Job ID

25-61469

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