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Senior Specialist Quality Assurance - Level III (Senior)

North Durham, NC 27712

Posted: 02/24/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 617986 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 40-55.15/hr **salary will be commensurate with experience

Job Description:


Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.
• Reporting to the Quality Assurance Organization, will independently manage project assignments.
• Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills.
• Immediate project support on review and approval of commissioning and qualification (C&Q) documents to support project delivery.
• Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, other technical documents, change management, and manufacturing/batch documents to meet schedule milestones.
• Ensure all aspects of the project proceed in compliance with cGMP, regulations, and our Companys Quality Management System.
• Focusing on areas such as Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizer, etc.).
• Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports.
• Consults on an as-needed basis with next level manager on more complex decisions.

Comments/Special Instructions
Completion of BCG Medical Surveillance required prior to start of work
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. 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 3 years of experience with development, review, and approval of User Requirement (URS), FAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities and utilities.
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About North Durham, NC

Ready to elevate your career in North Durham, North Carolina? This vibrant area is brimming with job opportunities and endless possibilities for professional growth. Nestled in the heart of the Triangle, North Durham offers easy access to renowned universities, such as Duke University and UNC Chapel Hill, a thriving tech and healthcare sector, and a rich cultural scene including the Durham Performing Arts Center, American Tobacco Campus, and the Durham Bulls Athletic Park. Immerse yourself in the local foodie culture with must-try dishes like Carolina barbecue and visit the Eno River State Park for a peaceful retreat into nature. Explore our job listings today and discover why North Durham is the perfect place to take your career to new heights!