Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Job title: QA Shop Floor Lead

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.

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?

Context of the job:

This Quality position ensures Quality Compliance oversight with cGMP, Regulatory, and Internal requirements regarding the manufacturing, testing, and distribution of products through real-time, on-the-floor presence.

Quality oversight involves, but is not limited to: deviation support, auditing of manufacturing areas for performance, regulatory audit support, documentation support, trending, risk assessments, adherence to the program as documented, and review of area release documentation following non-routine events.

This Quality position ensures Quality Compliance oversight for auditing, deviation support, technical advice, real-time coaching, support traffic and gowning, aseptic technique, cleaning and disinfection, aseptic process simulation procedures, gowning scenario decision making, documentation support, trending analysis, risk assessment, adherence to site programs, area releases, and other non-routine events. 

Objectives:

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

Increase quality culture in the manufacturing areas.

Provide guidance to resolve compliance issues and procedural errors in real time.

Perform periodic shop floor audits/walk-throughs.

Collaboration with the Manufacturing floor on critical investigations and implement robust preventative actions.

Enhance technical knowledge of operators and shop floor managers by providing positive and constructive feedback.

Main Responsibilities:

• Direct Reports of 3 or more individuals

• Area Lead for platform

• Establish scheduling and building support

• Identify efficiency gains within the department

• Drive for Quality Improvement on the manufacturing floor

• Manage day-to-day shop floor QA activities

• Mentoring/Coaching of QA Shopfloor managers

• Training for new QA shopfloor managers

• Collaboration with manufacturing floor

• Deviations Support – Risk Assessments and Closures

• Audits, walk-throughs, GEMBAs, technical coaching

Dimensions/Scope:

• This position includes managing technicians/managers specifically at Swiftwater, PA.

• This position is a 1st Shift Monday-Friday.

About You

Education/Experience:

• Bachelor’s Degree or Higher in a science-based or related field.

• A minimum 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,  cGMPs and regulatory requirements.

• Preferred experience in managing people, decision making, leadership, auditing, and deviation investigations.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.