Sanofi Group Quality Control Senior Analyst in Allston, Massachusetts
**Monday-Friday- 1st shift (Flexible on start time)
This position is responsible for qualifying analytical and microbiological testing instrumentation for the Genzyme Allston Landing Facility.
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.
Establish and maintain Equipment History Files (EHF) for QC laboratory equipment. Routinely assumes leadership role for instrument qualification.
Coordinate all services provided by vendors, ensuring vendors 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 as they relate to laboratory instrumentation.
May represent the organization in providing solutions to difficult technical issues associated with specific projects.
Revise standard operating procedures as needed.
Work independently with minimal supervision and direction.
Practice safe work habits and adhere to Genzyme's safety procedures and guidelines Demonstrate an understanding of CGMP's and 21 CFR compliance and how it applies to laboratory instruments
Exercise sound judgment and decision making when problem solving
Bachelor's Degree in Chemistry, Life Sciences, or Engineering discipline and 4 years of Industry relevant experience Or Master's Degree in Chemistry, Life Sciences, or Engineering discipline and 2 years of Industry relevant experience
Minimum of 2 years of experience related to instrument qualification in a regulated environment such as GMP.
Demonstrated scientific technical writing ability. Knowledge of USP 1058 and GAMP methodology. Knowledge of21CFR Parts 11,210,211,600 and 610. Experience with Empower and LIMS systems.
Previous hands on experience performing laboratory equipment qualification. Proficient in Outlook and Microsoft Word and Excel and lab based data management systems.
Special Working Conditions
Must be able to lift 40lbs
Must be able to gown for entry into the QC lab area
Must be able to work on a flexible schedule on a periodic basis based on business need
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life