QA Shop Floor Specialist
Sanofi

Job title: QA Shop Floor Specialist

Location: Ridgefield, NJ

Shift: 12pm to 8pm

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 for this position is 12pm to 8pm.
  
• 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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