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Manager Quality Compliance-Swiftwater, PA

Swiftwater, Pennsylvania

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Overview

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  • Problem-Solver
  • Results-driven
  • Team player

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Culture: Play to Win

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    Growth

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    Efficiency

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    Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"Patients are at the center of our work. Our teams focus on advancing transformational therapies, and expanding patient access to our medicines."

Mouhamed Gueye US Head Medical, Rare Blood Disorders

Responsibilities

**1st and 2nd shift positions with holidays and weekends as per business needs**

**Oversee the quality and compliance of product**

**Shop Floor position**

Job Description:

This Quality position ensures Quality Compliance oversight with cGMP, Regulatory, and Internal requirements regarding the manufacturing, testing, and distribution of products through real-time, on-the-floor presence.

Quality oversight involves, but is not limited to deviation support, auditing of manufacturing areas for performance, regulatory audit support, documentation support, trending, risk assessments, adherence to the program as documented, and review of area release documentation following non-routine events.

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

Objectives:

  • 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 the 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.

Key Responsibilities:

  • Product Pathway Assessment
  • Tagging area/equipment out of service
  • Releasing area/equipment back in service
  • Area/Line Clearances
  • Review Documentation – Logbooks, SRNs, Daily Releases, Batch Records, etc.
  • Deviations Support – Risk Assessments and Closures
  • Aseptic behavior review and coaching
  • Aseptic Process Simulations / Interventions Observations
  • Audits, walk-throughs, GEMBAs, technical coaching

Education/experience

  • Bachelor’s Degree or Higher in a science-based or related field with a minimum of 1-3+ years’ experience, in a Quality Role, in a cGMP controlled/ pharmaceutical industry with demonstrable working knowledge of documentation review, deviation investigation, contamination control, disinfection, quality assurance, aseptic processing, cGMPs and regulatory requirements. 
  • Preferred experience in decision making, leadership, auditing, and deviation investigations.

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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