Job title: QA Shop Floor Specialist

Location: Ridgefield, NJ

Shift: 10pm to 6am

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Biosurgery Quality Team as a QA Shop Floor Specialist and you’ll ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA walkthroughs, Audits and Investigations that may result in additional training and recommendations to procedural improvements.  Evaluate and provide QA recommendations for all products, systems, facilities, and issues that are affected or may be affected by regulatory or cGMP requirements. 

Increase quality culture in the manufacturing areas.  Enhance technical knowledge of operators and shop floor managers by providing positive and constructive feedback.

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:

Conduct QA Shop Floor Walkthrough and Audit based on schedule and assignment

Documentation of appropriate findings and support area improvement

Support the Lead and Manager to drive QA shop floor program and address concerns with manufacturing and driving quality improvements

Mentoring and coaching QA Shopfloor personnel

Coaching manufacturing team, when required

Collaboration with manufacturing on process improvements

Area/Line clearances, when requirerd

Review documentation- BPRs, Logbooks

Deviation support, when required

Perform audits, walk-throughs, GEMBAs, technical coaching

Support Lead and Manager with tasks as needed (Change Control, Deviations etc)

Support Additional Quality functions (Media Fill Observer, Documentation Updates etc)

About You

Basic Qualifications/Requirements:

Bachelor's Degree in Life Sciences or Engineering; 3-4 years’ experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements.

Or 5 years or more of relevant experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements.

The shift of this position is 10pm to 6am.

Advanced knowledge of MS Office including Excel, PowerPoint, and Word.

Preferred Qualifications:

Decision making, auditing, and deviation investigations.

Demonstrated willingness to learn, teamwork abilities, excellent communication, adaptability, organizational and analytical skills, and a strong interest in the pharmaceutical and bio-pharmaceutical industry.

Must have excellent written and verbal communication skills

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.