Job title: QA Specialist

Location: Swiftwater, PA

Monday - Friday 1st shift

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?​

The QA Specialist will 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 procedures.

Quality oversight includes, but is not limited to deviation support, auditing of manufacturing areas for performance, regulatory audit support, documentation support, trending, adherence to site programs, and review of area release documentation following non-routine events.

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

Foster best-in-class performance by leveraging data, technology and diverse talents to transform to a Proactive Quality Mindset and Drive Best in class Quality performance. Identify potential Simplification, Efficiency and Cost Savings gains and balance thoughtful risk taking in everyday decision making.

This position is primarily a Shopfloor position but will also have Quality System Responsibilities. This position will support all the Biologics areas as needed.

Main Responsibilities:

• Tagging area/equipment out of service

• Releasing area/equipment back in service

• Review Documentation – Logbooks, SRNs, Daily Releases, Batch Records, etc.

• Aseptic behavior review and coaching

• Aseptic Process Simulations / Interventions Observations

• Audits, walk-throughs, GEMBAs, technical coaching

• Deviations Support – Risk Assessments and Closures

Other Responsibilities:

• Participate in project teams involved with the facilities, processes and equipment for the manufacturing of vaccines

• Ensure a constant state of inspection readiness and all audit observations are addressed

• Support FDA and international regulatory bodies during site inspections

• Provide input and guidance to the team conducting incident investigations

• Make recommendations to department management regarding results of investigations and process improvements

• 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.

• First responder to address any non-routine events on shop floor.

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

• Perform periodic shop floor audits/walk-throughs.

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

• CAPA and Change Control Support

About You

Basic Qualifications:

• A Bachelor’s Degree is required

• 5-7 years’ experience in a cGMP production facility

• 1-3 years' experience working with Quality systems

Technical Competencies:

• Quality Assurance experience in a Pharma/Vaccine production facility

• Working knowledge of cGMPs, Regulatory and Global requirements

• Knowledge of vaccines/biologics products and associated technologies

• Previous experience with upstream processing of Drug Substance and/or Quality Control testing in a cGMP facility

• The ability to work on cross-functional project teams

• Meet/Exceed project timelines/deliverables

• Experience with Quality Systems including SAP, Qualipso, LabWare and MS Office. Knowledge of OneQuad, InQ, SMS 2.0, OpsTrakker

• Demonstrate four core Sanofi values - Aim Higher, Act for Patients, Be Bold, and Lead Together.

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:

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.