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QC Sample Management Senior

Company: myGwork
Location: Framingham
Posted on: November 22, 2022

Job Description:

POSITION OVERVIEW Department : The Quality Control Sample Management (QCSM) group supports the Quality Control (QC) Organization at Framingham Biologics. QC Sample Management is responsible for Sample Receipt of QC samples, chain of custody requirements, retains and reserves, verification of the accuracy of the materials submitted and entry and receipt into the various digital system and business tools that support QC operations. This includes supporting the QC Laboratories across the Framingham Campus and coordinate shipment of testing samples to contact testing sites. Sample Management aims to provide timely and dependable operational support to the QC Chemistry, QC Microbiology and QC Biopolymers groups on a daily basis to ensure timely and right the first time delivery of test results required by Manufacturing Operations groups and Quality Assurance. This position is Wednesday to Saturday shift, 8:30 AM to 7:00 PM Key Responsibilities may differ among employees with the same job title and may change over time in accordance with business needs. This is a fast paced, highly complex environment, where individuals will be expected to:

  • Coordinate distribution of samples to other laboratories and sample requiring send out, domestic and international, maintain chain of custody.
  • Mentor and train laboratory coordinators, maintains qualification status.
  • Identify and investigate departures from QC procedures, provides guidance to more junior staff.
  • Recommend improvements, manages CAPAs.
  • Review data entry and logbooks for compliance to procedures.
  • Order of laboratory supplies, including Capital expenditures and monitor standing purchase orders.
  • Manage laboratory reserve samples, provides oversight of discards, coordinate and schedule annual inspections.
  • Attends meetings as department representative or delegate.
  • Schedule major activities within Sample management. Provide technical leadership and guidance for the successful completion of major laboratory projects:
    • Subject matter expert for Sample Management, interacts with auditors during inspections, maintains inspection readiness.
    • Develop complex and explicit documentation to implement new procedures, performs periodic review of current procedures.
    • Implement and monitor personnel training.
    • Work effectively with others to achieve shared goals.
    • Effectively demonstrated competency of CGMPs and Data integrity practices, promotes compliance culture.
    • Communicates effectively cross-functionally and escalates issues.
    • Works independently with minimal supervision, must have demonstrated ability to make decision using critical thinking and problem solving and provide guidance to staff. This includes during non-standard hours when management is not on-site.
    • Practices safe work habits and helps to promote safety procedures and guidelines. Basic Qualifications:
      • High School Diploma with minimum of 8 Years of relevant industry experience or an equivalent combination of education and experience may substitute.
      • Previous experience in Sample Management or a GMP role
      • Critical thinking and problem-solving skills.
      • Excellent interpersonal and communication skills
      • Demonstrated competency of CGMPs and Data integrity practices
      • Proficient with Microsoft Office tools such as: Word, Excel Outlook & PowerPoint

        Preferred Qualifications:
        • Experience with Laboratory Information System (LiMS)
        • Strong attention to detail and demonstrated organizational skills due to the complexity of the samples received and systems uses.
        • Ability to adapt and adjust to changing priorities and to manage assignments with challenging/conflicting deadlines due to expiry and delivery timelines
        • Ability to work in a high-paced team environment and meet deadlines
        • Ability to communicate effectively with peers and department management S pecial Working Conditions:
          • Must be able to lift 40 lbs.
          • Must be able to work with Spor-klenz solution, which is used to sanitize equipment following SOP guidelines.
          • Position is considered essential personnel and may be required to staff the lab during inclement weather events As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. 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. #GD-SG

            #LI-GZ 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. This employer is a corporate member of
            myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals,
            students, inclusive employers & anyone who believes in workplace equality.

Keywords: myGwork, Framingham , QC Sample Management Senior, Executive , Framingham, Massachusetts

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