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Associate II, Quality Control, Sample Management


Location: Norwood, Massachusetts
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The Role:
The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs.   Also, this individual may support special projects as assigned.  This is a 2nd shift role Sunday through Wednesday

Here’s What You’ll Do:

  • Sample coordination including cross functional collaboration with internal and external labs

  • Receipt, processing, distribution and shipment of the following sample types:

    • In-Process, DS, Formulation and DP

    • Equipment cleaning

    • Stability

    • Raw Materials

  • Coordinating domestic and international sample shipments

  • Communication with external Contract Test Labs (CTLs)

  • Inspect product and raw material retention samples

  • LIMS (LabVantage) sample logging and result entry

  • AQL visual inspection of drug product

  • Stability program support

  • Controlled temperature unit management, maintenance and troubleshooting

  • Clean room gowning

  • Managing/stocking of QC lab supplies

  • Write/revise SOPs, protocols and reports

  • Complete and maintain cGMP documentation for work performed

  • Participate in authoring quality systems records such as deviations, change controls, CAPAs

  • Support non-conformance investigations

  • Establish and maintain a safe laboratory working environment

Here’s What You’ll Bring to the Table:

  • Minimum experience/education required: Bachelor’s degree in a relevant scientific discipline with 2+ years in a cGMP laboratory setting preferred

  • Minimum knowledge required: cGMPs, general laboratory safety

  • Minimum skills required:

    • Pipetting, preferred to be done aseptically

    • Familiarity with electronic databases (e.g. LIMS, SAP, eQMS, CMMS, LMS)

    • Proficiency with Microsoft Office Programs

  • Strong written and oral communication skills as well as organizational skills

  • Knowledge of industry standards and guidelines

  • Demonstrated ability to work effectively under established guidelines and instructions

  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.

  • Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.

     

 


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