Quality Assurance Shop Floor Lead

Job title: Quality Assurance Shop Floor Lead

Location: Ridgefield, NJ

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. Your job, as Quality Assurance Shop Floor Lead within our Biosurgery Quality Team will be to 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 (for both Sanofi locations)

• Documentation of appropriate findings and support area improvement

• Support the 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 Manager with tasks as needed (Change Control, Deviations etc)/

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

• Author significant and non-significant deviations, change controls, report etc.

• Present department KPIs as needed 

About You

Basic Qualifications/Requirements:

• Bachelor's Degree in Life Sciences or Engineering; 5+ years’ experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements.

• OR 6 years of relevant experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements + High School Diploma or equivalent.

• Flexibility with shifts. Primarily 1st shift however 2nd and 3rd shift presence when required.

• 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