Sanofi Group Quality Control Principal Investigator in Meriden, Connecticut
The QC Principal Investigator will work cross-functionally with analysts, managers, and various support groups to investigate root causes for Out of Specification and Out of Trend test events in the QC area. In collaboration with QC Management, the incumbent will lead deviation investigations and drive change controls in the QC laboratory. Also, will support the implementation of activities for Quality Control CAPA’s and continue improvements.
Lead laboratory investigations and actions as required in Quality Control. Acting as QC initiator of quality event as initial laboratory investigations, deviations, and change controls.
Drive on-time closure of quality events gathering data from various sources across multiple groups.
Collaborate with Manager to write and review of quality documents (Protocols/Reports, SOP, PNM, WI) in accordance with cGMP and regulatory guidelines.
Identify and support continuous improvement efforts in the laboratory in collaboration with the QC management.
Support self-audits including laboratory walk throughs and drive remediations through the area managers.
Support test method transfer between PSC departments, Sanofi Pasture sites or external testing labs.
Bachelor’s degree required, preferably in one of the following fields of study: Chemistry, Biochemistry, Quality, Biology or Bio/Molecular Engineering AND
Minimum 3 years' in a cGMP / Regulated industry, preferably within pharmaceutical / biotech AND
Experience in either a Quality Control Laboratory or in a Quality Assurance role AND
Knowledge of continuous improvement techniques and problem-solving skills AND
Professional and expert technical writing capability
Compendial testing methodologies (USP, Ph. Eu, etc.).
Familiar with analytical instrumentation in a cGMP compliant environment.
An understanding of routine QC operations including testing.
Experience with laboratory electronic systems.
Proficient using Microsoft Office.
Proven logic and decision-making abilities and critical thinking skills.
Proven leadership, verbal and written communication, organizational, critical thinking, and action-oriented.
Certifications: Not required but preferred.
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.