JVT Advisors

QC II, GMP Sample Management (3)

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length:  6 months with possible extension or conversion

Job Summary:  The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs.

Responsibilities:

  • 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

Requirements:

  • 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.

Rich Griffin, Jr.

Business Development Manager

Rich specializes in establishing new accounts and expanding current accounts, with a concentration in healthcare technology and general IT.

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