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QC Coordinator III

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LanceSoft, Inc.

2021-12-03 08:58:20

Job location Lexington, Massachusetts, United States

Job type: fulltime

Job industry: Science & Technology

Job description

Job Title: QC Coordinator III

Location: Lexington MA 02421

Duration: 06 Months


Key Accountabilities:

  • Provide internal stability tracking and trending for drug substance, drug substance intermediate and drug product using software appropriate to stability and expiry extension. Provide oversight of stability studies at external vendors and reviews data.
  • Familiarity with a full range of analytical techniques, review and evaluate raw data from all analytical methods (UPLC, qPCR, ELISA, NTA and DLS).
  • Leads laboratory deviations and investigations (IA, OOS, OOT) and provides investigation closure.
  • Author stability protocols and reports.
  • Lead and participate in providing the necessary information for regulatory filings and inspections.
  • Lead and support CAPA/Continuous Improvement Initiatives.
  • Participate in the development and revision of product specifications; provide scientific input and statistical analysis of results.
  • Analyze stability studies for tracking and trending quality attributes.
  • Develops and executes continuous improvement initiatives to ensure the QC organization meets key performance indicator goals
  • Coordinate stability pulls from all internal stability studies, manage sample shipments to and from storage and testing sites, monitor and review data received from external sites.
  • Manage the QC laboratory testing schedule.
  • Resolve technical problems through scientific understanding, options assessment, and application of innovative solutions.
  • Generate complete, accurate, and concise laboratory documentation.
  • Comply with safety guidelines, cGMPs and other applicable regulatory requirements.

Skills:

  • Background in Quality Control Laboratory environment and Laboratory Operations.
  • Strong knowledge of cGMP/ICH/FDA/EU regulations.
  • Strong analytical, communication, presentation, and writing skills.
  • Able to interpret data
  • Perform assigned, complex and/or varied tasks
  • Ability to plan, organize and execute on stability studies, and manage multiple projects simultaneously.
  • Ability to work cross-functionally in a fast-paced team environment.
  • Proven track record of being personable, energetic, responsive, empowering, inclusive, action-oriented, accountable, and an effective communicator.

Education:

  • Bachelor in Biochemistry, cell biology or similar.
  • MS in Biochemistry, cell biology or similar (preferred)

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