Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 

This position ensures Quality Compliance oversight with cGMP, Regulatory, and Internal requirements regarding the manufacturing, testing, and distribution of products through formal QA audits, change controls, investigations, development of corrective and preventative actions, training and review and approval of procedures, protocols and reports.  Evaluate and provide QA recommendations on all products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements.

This position is a 1st shift, Monday-Friday, and subject to move based on business justification.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Ensure a constant state of inspection readiness and that all audit observations are addressed quickly and completely to maintain readiness levels.

• Complete incident investigations through the review and approval process 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.  Make recommendations to department management regarding results of investigation and process improvements, when necessary.  Manage the CAPA system to ensure that corrective and preventative actions are developed and implemented.

• 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 necessary follow up with respective functional area management to ensure cGMP audit observations are implemented.

• Provide support to functional areas regarding the Change Control System by providing assessments, work closure and follow up.  Recommend documentation and supporting data to include in the Change Control Request to ensure that enough information is provided to the Change Control Board so that an informed decision can be made.

• Provide final signatory review and approval for SOPs, SWIs, and Master Manufacturing Records to ensure compliance with cGMP, regulatory and internal requirements.

• Interact successfully within the highly energized production and regulatory environments.

• Interact regularly with site counterparts relating to manufacturing, testing, disposition, and cold chain documentation.  The incumbent must be able to communicate clearly the cGMP requirements.

• Provide shop floor quality support to ensure manufacturing activities are performed in compliance with effective SOPs & SWIs.

• First responder to address any non-routine events on shop floor for the assigned area. Provide guidance/decision to resolve compliance issues and procedural errors in real time.

• Increase quality culture in the manufacturing areas by providing positive and constructive feedback.

About You

Education/Experience

• Bachelor's Degree in Science or related filed, with 5-8 years experience in a GMP regulated environment.

• 3-5 years experience, in a Quality Role, in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of documentation review, deviation investigation, contamination control, disinfection, quality assurance, aseptic processing, cGMPs and regulatory requirements.

• Preferred experience in decision making, leadership, auditing, final closure review of deviation/non-conformance investigations and batch disposition determination.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.