Quality Assurance - Vaccine (3rd Shift)
Swiftwater, Pennsylvania
Overview
From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.
Success Profile
Do you have what it takes for a successful career with Sanofi?
- Courageous
- Results-driven
- Proactive
- Problem-Solver
- Leadership
- Team player
Culture: Play to Win
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Growth
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Innovation
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Efficiency
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Collaboration
Benefits
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Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
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Financial
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
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Culture
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
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Work/Life Balance
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
Quote
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."
Shannon Resetich
US Head Rare Diseases & Blood Disorders
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."
Mouhamed Gueye
US Head Medical Rare Blood Disorders
Responsibilities
Quality Compliance Official - Vaccine
Tues - Sat, 3rd Shift Position (Shop Floor Quality)
Swiftwater, PA
POSITION SUMMARY:
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.
POSITION RESPONSIBILITIES:
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.
EDUCATION/EXPERIENCE:
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.
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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.
