Quality Assurance - Vaccine (3rd Shift)
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Quality Compliance Official - Vaccine
Tues - Sat, 3rd Shift Position (Shop Floor Quality)
Ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA Audits, investigations, training, and recommendations to improve processes / procedures. Evaluate and provide QA recommendations on all products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements.
Ensure a constant state of inspection readiness and that audit observations are addressed on time and completed to maintain readiness levels.
Provide daily floor coverage to support compliance of production, development, and testing of all products within functional areas. Audit areas to ensure compliance with cGMP, regulatory, and internal requirements.
Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation. Identify and communicate cGMP compliance deficiencies to upper management, recommend appropriate corrective actions when necessary, and perform monitoring with respective functional area management to ensure compliance.
Complete risk assessment, minor, and major incident investigations in response to any unexplained events encountered during manufacturing or out-of-specification lab results for functional areas. Provide input and guidance to the team conducting the investigation.
Manage the CAPA system to ensure that corrective and preventative actions are implemented and completed on time. Provide recommendations to department management regarding CAPA development for process improvements.
Provide support to functional areas regarding the Change Control System by providing assessments, closure, and monitoring. Recommend documentation and supporting data to be included in the Change Control, so proper assessments of cGMP areas can be evaluated, and risk mitigated.
Provide final signatory review for SOPs, SWIs, and Master Manufacturing Records to ensure compliance with cGMP, regulatory and internal requirements such as company guidelines and approved procedures.
Interact successfully within the highly energized production and regulatory environments, to ensure compliance, mitigate risk, and ensure products are safe for patients.
Interacts regularly with site counterparts relating to manufacturing, testing, disposition, and cold chain documentation. The incumbent must be able to clearly communicate the cGMP requirements.
Interacts with internal / external auditing bodies. Ability to present / describe / articulate processes, and documentation to auditors may occur.
Bachelor's Degree in Science, with ≤ 3 years quality experience preferred in a GMP regulated environment.
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.