Sanofi Group Lead Quality Control Analyst - Vaccine in Pearl River, New York
The individual in this role will provide a lead role in all aspects of day to day functions of the laboratory and assist the laboratory management in method trouble shooting, Instrument and Assay issues , and address laboratory investigations and CAPA’s. The role will also entail the mentoring of junior analysts in assay execution and training as directed by the lab management.
LOCATION: Meriden CT
Monday-Friday- 1st shift position
Hands on expertise with a thorough understanding of the analytical basis in methodologies such as ELISA , PCR , Immunochemical Assays or HPLC , Spectrometric methods , Compendial testing. The incumbent should be able to follow testing schedule as well as troubleshoot instrument issues, remediate sample discrepancies, and perform training.
The candidate should have experience with development and validation of analytical methods analytical technical transfers and support generation of associated documents including SOP’s, Protocols and Reports.
Ability to support training of others on the theory and technical components of the tests and processes used within the department.
The candidate of this role will assist with maintaining safety and compliance of the laboratory work area; Coordinate cleaning of laboratories, equipment, and ancillary areas as required; Attend/Contribute to scheduled team meetings, department and safety meetings.
Performs review of laboratory documentation. Initiate and manage laboratory investigations, OOS, OOT and other aberrant results.
Performs additional activities related to QC laboratory operations when required.
Bachelor's science degree in Chemistry/Biochemistry/Biological Science/Molecular Biology or related field with more than 6 years in a cGMP/Quality environment required OR
Master’s degree with 3 years of relevant work experience in a cGMP/Quality environment required.
2 years of hands on experience in methodologies such as HPLC or ELISA, PCR.
A familiarity of the QC processes including investigations, Change controls and data integrity concepts.
Exceptional attention to detail and strong writing skills are crucial. Individual must be familiar with cGMP guidelines.
Candidate must be able to work in a team environment.
Familiarity with Statistical concepts and ability to conduct simple statistical analysis of data. Knowledge of electronic documentation systems in a cGMP environment.
Knowledge of routine QC processes and basic understanding of Biologics manufacturing.
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.