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Featured Positions
REQ #16566 Manager, Biochemistry Position Description and Responsibilities: Hire, train, and develop qualified QC technical personnel. Supervise Biologics QC Biochemistry group for release and stability testing of biological products in a GMP environment. Ensure GMP compliance and efficiency in all aspects of laboratory operations. Develop and implement SOPs for various QC operational procedures. Oversee stability study and complete testing within required sample cycle time. Perform data trending analyses and the preparation of protocols and reports. Investigate OOS results and write investigation reports. Assist and coordinate technology transfer activities. Position Requirements: B.S., M.S., or Ph.D. education and technical training in relevant areas of chemistry or biochemistry. Hands-on experience in HPLC preferred. Experience in management of release/stability testing or analytical method development in a GMP environment. In-depth knowledge of GMP regulations and related guidance for QC operations. At least 5 years of pharmaceutical industry experience. A minimal of 3 to 5 years pharmaceutical QC or analytical development experience. Familiar with operating procedures for QC analyses of drug substance and drug product, and those for stability studies. Experience in managing scientific or operation personnel. Proficient in technical writing. Basic knowledge in operations management. Excellent leadership, communication, and team building skills. Interested candidates please forward your resume and cover letter to info@mcguireglobalrecruitment.com  REQ #14841 - QA AuditorPosition Description and Responsibilities: Will organize and lead internal quality audit teams performing formal audits of manufacturing, material and laboratory operations in a cGMP environment. Functions include the scheduling of audits with internal partners, leading opening closing meetings, evaluation management of all observations, tracking of audit responses within TrackWise and Quality metric trending and analysis. The auditor role will also assist with preparation of Syracuse site for regulatory inspections and responses to regulatory agencies, corporate audits and external audits. Additional functions are inclusive of performance of vendor audits and other audits as required. The auditor will proactively work as a site educational source for new cGMP guidelines requirements. Position Requirements: B.S. degree in Engineering, Pharmacy, Biotechnology, or Biology with at least 5 years experience in the pharmaceutical industry. Three years in Quality Assurance is required. Biotechnology or Biopharmaceutical experience is preferred. Previous auditing experience is required. Must possess a broad knowledge of relevant governmental regulations, cGMPs and guidelines. Position requires excellent communication, technical writing and computer skills. Must be a Certified Quality Auditor American Society for Quality or equivalent or ability to achieve certification. Interested candidates please forward your resume and cover letter to info@mcguireglobalrecruitment.com |
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