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Quality Technician

Swiftwater, Pennsylvania

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.

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Rewards

  • HEALTH AND WELLNESS PROGRAMS

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

  • EMPLOYER MATCHING

    Employer matching because Sanofi invests in their employees!

  • PROFESSIONAL DEVELOPMENT

    Sanofi is eager to further your development and expertise in an ever challenging environment.

  • FAMILY SUPPORT

    Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.

  • PAID TIME OFF

    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

  • WORK/LIFE BALANCE

    Importance of life outside of the office is valued at Sanofi.

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Responsibilities

Job Summary:

This position performs quality inspections on incoming material, which includes verification of supplier documentation, statistical sample removal, visual inspection, dimension testing, and status tagging of materials by strictly adhering to Sanofi Pasteur policies and procedures and cGMP.  The position is required to perform cleaning of work areas, equipment, and any other jobs, as required.

  • The position requires that the incumbent interact with external customers as a representative of Sanofi Pasteur Quality Operations.  External companies include raw material vendors and other Sanofi sites on a global level. 
  • The incumbent must process raw material batches to ensure timely disposition within agreed upon timelines to support production scheduling and or marketing expectations.
  • The incumbent must work within the policies, procedures, and regulations as required by the Company and under the Occupational Health and Safety Act.
  • Attention to detail in recording GMP data right first time into GXP documents. 
  • The ability to handle multiple priorities (and respect timelines) is required in order to surpass milestones.
  • The ability to negotiate, work with and influence a variety of people in a positive manner while identifying, and working to solve problems is a requirement of the position.  
  • The incumbent must be able to work effectively with colleagues at other sanofi, contract sites, and outside vendors to ensure that GMP data is available in a timely manner.

Each individual working in a GMP area is responsible for following the documented processes and recording GMP data correctly.  Non-compliance in following a GMP process or procedure may result in regulatory observations, up to and including recall, and a significant risk to the site’s continued operation.

Key Accountabilities:

  • Performs inspection, sampling, testing, and release of raw materials by strictly adhering to SOPs, SWIs, material specifications, Federal Regulations, cGMP, training modules, sanofi pasteur policies and procedures, and safety guidelines.  These activities are performed as dictated by PQ MR management to meet the demands of the production schedule.
  • Maintains laboratory in a safe and compliant state.  Manages inventory of raw material sampling utensils, sample containers, and safety supplies.  Performs cleaning of laboratories sampling equipment.

  • Processes and inspects product samples from contract manufacturers.  Ensures cold chain of custody is kept on samples and samples are distributed to the applicable testing unit.  Ensures cold chain of custody is maintained.

  • Performs status tagging for raw materials within the Building 38 warehouse and associated off site warehouse locations.  Performs status tagging for intermediates, final bulks, final containers, and finished product released by PQ Batch Release.

  • Understand and support implementation of change controls, CAPAs, and deviation corrective actions.  Notifies lab manager of any deviations or issues and initiates deviation investigations as required.  Supports deviation investigations.

  • Attends and contributes to scheduled team meetings, department meetings, and safety meetings.  Performs document and procedure review as needed.  Trains on departmental training modules as assigned.  Pursues professional and or technical development training on/off site.

Education & Experience:

  • HS Diploma/GED with 3-5 years’ experience OR BA/BS with 1-3 years’ experience
  • Excellent organizational, written, interpersonal, leadership and teamwork abilities.  Excellent working knowledge of cGMPs (US, Canada, Japan, Europe). Experience in SAP, LabWare, EDMS, Trackwise, Aseptic Technique is beneficial. 
  • Fork lift certification preferred

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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