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ApTask · 3 months ago

Senior Specialist Quality Assurance - Level III (Senior)

Durham, NC

Full-time

Onsite

Mid, Senior Level

$54/hr - $55/hr

2+ years exp

ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. They are seeking a Senior Specialist Quality Assurance who will be responsible for ensuring compliance with regulatory expectations in the pharmaceutical industry, particularly regarding sterile manufacturing and quality assurance oversight.

Human ResourcesInformation TechnologySmall and Medium BusinessesStaffing Agency

Growth Opportunities

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

Batch record review/approval

Technical protocol review/approval

Equipment qualification protocol review/approval

Deviation review/approval

Execute shop floor quality audits

Qualification

Quality AssurancePharmaceutical IndustryRegulatory ComplianceSterile ManufacturingProcess ValidationSAPTechnical Protocol ReviewBatch Record ReviewQuality AuditsInterpersonal SkillsCommunication SkillsNegotiation SkillsRelationship Building

Required

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

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

Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills

Must have very strong relationship building skills