JVT Advisors

Senior Manager Quality Control

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Location: Bedford, Massachusetts 01730
Employment Type: Contract

Job Description

Contract Length: 6 months with possibility of becoming a full-time, permanent employee

Job Summary: The position is responsible for the development, implementation and maintenance of QC systems and standards, including the environmental monitoring program.

Responsibilities:

  • Provide direct management of all activities required for the testing and release of commercial products in a cGMP environment to include:
    • Testing and approval of raw materials, in-process samples, bulk and finished products
    • Environmental and personnel monitoring
    • Stability samples in conformity to standards and approved specifications
  • Drive and perform timely review of complete release testing and stability data for the raw material and finished product batches.
  • Participate in lab audits and lab investigations related to OOS & other deviations along with QA colleagues.

Requirements:

  • Bachelor’s degree in Chemistry, Microbiology or Biology
  • Minimum of 10 years of experience in a regulated QC biopharmaceutical or Medical Device industries
  • Previous experience within an aseptic facility or with aseptic sterilization techniques
  • Minimum of 5 years supervisory experience
  • Proven experience with technical writing skills to draft documentation, preparing technical reports, memos, and protocols.

 

Eric Carmody

Business Development Manager Life Sciences

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