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Job Title: Senior Quality Assurance Specialist - Pharmaceutical Manufacturing Location: Durham, NC Duration: 12 Months (Possibility of Extension) Qualifications: Bachelor's/Master's Degree in relevant life science or engineering discipline 5+ years of experience in pharmaceutical industry or highly regulated industry with Bachelor's degree or 3+ years with Master's degree Experience with review and approval of URS, FAT, IQ, OQ, PQ for manufacturing equipment, facilities, and utilities Strong knowledge of cGMPs, regulations, and industry trends Effective decision making, problem solving, and communication skills Ability to manage multiple priorities Demonstrated ability to work in fast-paced, complex environments Preferred Experience and Skills: GMP quality experience with biological drug substance or drug product GMP experience with equipment qualification Quality Risk Management experience Project Management experience in a highly regulated industry Experience with Kneat, SAP, Trackwise, and/or GLIMS Responsibilities: Ensure compliance with cGMP, regulations, and Quality Management System Manage project assignments related to manufacturing equipment, facilities, and utilities Review and approve technical documents such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, and technical reports Partner with site and above site functions to solve problems and achieve goals Make decisions guided by policies and procedures that impact the team's ability to meet performance objectives Consult with next level manager on more complex decisions as needed Special Instructions: Onsite role at Durham, NC for 1 year with possibility of extension Candidates with more than 8 years in QA and Validation/CQV/C&Q experience in manufacturing are preferred