Principal Analyst

Key Responsibilities: Coordinate activities relating to the qualification, calibration and maintenance of laboratory equipment and related systems. Coordinate the purchase, commissioning and introduction to service of new equipment. Coordinate all services provided by vendors, ensuring vendor meet all site requirements. Schedule/plan/execute validation activities and preventive maintenance of laboratory equipment. Monitor and ensure ongoing compliance of all laboratory equipment and associated systems. Provide training to analysts, as required. Develops and authors complex and explicit documentation to support instrument qualification. Prepares investigations related to instrumentation issues. Author protocols and technical reports related to the implementation of QC equipment. Follow written procedures that are related to laboratory instrumentation. Revise standard operating procedures as needed. Work independently with minimal supervision and direction. May represent the organization in providing solution to difficult technical issues associated with specific projects. Practice safe work habits and adhere to Sanofi Genzyme's safety procedures and guidelines. Demonstrate an understanding of cGMP and 21 CFR compliance and how it applies to laboratory instruments. Exercise sound judgement, decision making and problem solving. Basic Qualifications: Bachelor's degree in Life Science or Engineering discipline with 8 years of Pharmaceutical Industry experience. Or Master's degree in Life Science or Engineering discipline with 6 years of Pharmaceutical Industry experience. Or PhD in Life Science or Engineering discipline with 0 year of Pharmaceutical Industry experience. Preferred Qualifications: Demonstrated scientific technical writing ability. Knowledge of USP 1058 and GMAP methodology. Knowledge of 21 CFR Parts 11, 210, 211, 600 and 610 Experience with Empower and LIMS systems. Experience with laboratory analytical software applications. Previous hands on experience performing laboratory equipment qualification. Proficient in Outlook, Microsoft Word, Excel and lab based data management systems. Special Working Conditions: Ability to gown and enter laboratory. Ability to lift 25 lbs. May require off shift work to support activities. R2482019
Salary Range: NA
Minimum Qualification
8 - 10 years

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