Job title: Senior Pharmaceutical Quality Specialist – SPQS 25
Company: NavitsPartners
Job description: Job Title: Senior Pharmaceutical Quality Specialist
Location: Durham, NC 27712 (Fully Onsite)
Duration: 12 MonthsRate: $50.00/hr (W2)Note: X-Ray Test and TB Test are required – please confirm candidate compliance.Job Description:We are seeking a Senior Pharmaceutical Quality Specialist to provide Quality Assurance support for a pharmaceutical manufacturing project. The ideal candidate will have experience preparing sites for Pre-Approval Inspections and ensuring compliance with cGMP and regulatory standards.Key Responsibilities:Provide support for manufacturing site assessments and preparation for Pre-Approval Inspections by regulatory agencies for new product introductions.Work independently under the Quality Assurance Organization to manage assigned projects.Review and approve commissioning and qualification (C&Q) documents for equipment and facility startup.Critically review and approve GMP documentation including:Quality AgreementsQuality Risk AssessmentsUser Requirements Specifications (URS)Factory Acceptance Testing (FAT)Installation/Operational/Performance Qualifications (IQ/OQ/PQ)Change Controls, SOPs, Validation Protocols, and Technical ReportsManufacturing and batch records (master and executed)Ensure project activities are conducted in compliance with cGMP, regulatory expectations, and internal Quality Management Systems.Focus areas include Qualification and Compliance for sterile pharmaceutical manufacturing equipment (e.g., isolators, RABS, lyophilizers, autoclaves, washers, incubators, vessels, etc.).Collaborate cross-functionally and consult with management for complex decisions as needed.Qualifications:Bachelor’s degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or a related field.Minimum 5 years of experience in the pharmaceutical industry, preferably within Quality Assurance.At least 3 years of experience reviewing and approving URS, FAT, IQ/OQ/PQ documents related to pharmaceutical or biotechnology equipment and facilities.Hands-on knowledge of sterile product manufacturing, validation, and/or tech transfer.Strong interpersonal, communication, and negotiation skills are essential.
Expected salary: $50 per hour
Location: Raleigh, NC
Job date: Sat, 31 May 2025 22:38:32 GMT
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