QA Specialist

Job Title: Quality Compliance Official

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. 

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 will be responsible for the Shop Floor coverage, including providing guidance on issues that arise on the floor, audits, daily Gembas and other support as needed in alignment with SMS Express Lane QA Analyst role.

S-Tr or Tu -Sa Second Shift Position (Shop Floor Quality)

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main 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.

• 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.

• Communicate and Escalate non-conformances.

• Ability to read/write/understand procedures.

• Decision making with guidance commensurate on experience level.

• Ability to obtain and maintain Aseptic Gown Qualification

• Ability to obtain and maintain AQL Certification, including successful eye exam to support visual inspection.

• Fluent in all aspects of SMS pertaining to L1 as specific to the QA Analyst role.

• Ability to coach production on techniques/processes to procedure requirements.

• Lead small scale projects.

• Perform CCA sampling.

• Support off-day / holiday coverage (with in lieu of days) as required to support production.

• Ability to perform daily functions and with little supervision.

• Demonstrate leadership qualities within the organization.

About You

Education/Experience:

• Bachelor’s Degree in Science, with ≤ 3 years quality experience preferred in a GMP regulated environment.

• Accessing aseptic processing areas, sterile gowning, sampling technique, detail oriented, are requirements to support daily activities of audit readiness and product quality testing.

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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Pursue progress, discover extraordinary

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:

$67,500.00 - $97,500.00

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.