Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden
QA Shop Floor Specialist
Auf einen Blick:
Unsere Teams produzieren und liefern jedes Jahr über 4 Milliarden Einheiten an Medikamenten und Impfstoffen und sorgen dafür, dass jede Innovation die Menschen erreicht, die sie am dringendsten benötigen. Unsere hochmodernen Produktionsstätten, KI-gestützten Smart Factories und wegweisenden Automatisierungstechnologien setzen neue Maßstäbe – damit Behandlungen Patient*innen schneller, sicherer und nachhaltiger als je zuvor erreichen. Hier kannst Du mit Deinen Fähigkeiten, Deinen Ambitionen und Deiner Leidenschaft die Zukunft des Gesundheitswesens mitgestalten.
Job title: QA Shop Floor Specialist
Location: Ridgefield, NJ
Shift: 3pm to 11pm
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 with 2-3 years’ experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements.
Or 3 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 in lieu of degree
Must have Aseptic Manufacturing and Quality Auditing Experience
Has experience with Filling machines in Grade A
Worked in a Microbiology laboratory or Aseptic Production/Manufacturing Facility environment
Advanced knowledge of MS Office including Excel, PowerPoint, and Word.
The shift for this position is from 3 pm to 11 pm.
Preferred Qualifications:
Packaging experience is preferred
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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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.
Mehr Informationen über diesen Standort
Warum bei uns arbeiten?
- Wir stellen nicht nur Medikamente her – wir bewirken etwas. Unser globales Netzwerk modernster Produktionsstätten sorgt dafür, dass Patient*innen die Behandlungen erhalten, die sie brauchen – genau zur richtigen Zeit.
- Innovation treibt uns an. Von KI-gestützter Fertigung bis hin zu weltweit führenden Produktionsmethoden setzen wir neue Maßstäbe in Effizienz und Leistung.
- Hier wachsen Karrieren. Ob in der Produktion, Qualitätssicherung, Ingenieurtechnik oder in der Supply Chain– arbeitest Du mit erstklassigen Talenten zusammen, entwickelst Deine Fähigkeiten weiter und gestaltest die Zukunft der Pharmaindustrie mit.
- Wir tun, was richtig ist. Sicherheit, Nachhaltigkeit, Vielfalt, Gleichberechtigung und Inklusion stehen im Mittelpunkt unseres Handelns – für ein Arbeitsumfeld, in dem alle erfolgreich sein können.
All-In für Vielfalt
Bei Sanofi führen unterschiedliche Perspektiven zu den besten Lösungen für Patient*innen. Erfahre von Monique Vessey, unserer Leiterin der Supply Chain -Transformation, wie ihre persönliche Geschichte ihre Arbeit bei der Bereitstellung lebenswichtiger Medikamente prägt.
"Manufacturing & Supply bildet die Brücke zwischen der Wissenschaft in unseren Forschungslaboren und den Menschen und Gemeinschaften, die wir versorgen."
Brendan O’Callaghan
Executive Vice President of Manufacturing and Supply
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