• LFB USA - QC Stability Coordinator

    Job Locations US-MA-Charlton
    Job ID
    # of Openings
    Quality Assurance/Quality Control
    Full Time
  • Overview

    The Stability Coordinator/Writer is responsible for managing the Stability Program executed in the Quality Control laboratory.  Individual will integrate various sources of information into a uniform style and language for regulatory compliance and may coordinate the review, approval, and revision of SOPs, specifications and forms as needed. Works with initiators to rewrite, clarify, or reconstruct controlled documents. This position works closely with laboratory staff, Quality Control Management, Regulatory Affairs and Quality Assurance.


    • Responsible for coordination of stability testing with other lab activities. Coordination may include details such as materials, equipment and analyst availability.
    • Responsible for generating Stability Protocols, Stability Updates, and Stability Reports. Ensure that studies are initiated and executed according to FDA and EU guidelines.
    • Assist with data review, data tracking with QC Sample Database and associated tracking systems such as Master Testing Update, product specific summary files and study specific trending files.
    • Assist with coordination and management of control/standard qualification program.
    • Author or assist in generating written documents, such as Reference Standard reports, Annual Product Review, OOS Summaries, Validation Protocols/Reports and other documents that support the operation of the Quality Control laboratory.
    • Assist with the collation and review of data packages for the release of composite, intermediate, drug substance, and drug product.
    • Assist with the collation and review of data packages and the generation of Data Summaries (as needed for Study data).
    • Assist with the preparation and submission of original data packages to Quality Assurance.
    • Coordinate logging and shipping of QC samples.



    • BS degree (preferred) in a scientific discipline. 2+ years’ experience in a QC/GMP environment.
    • Excellent organizational skills with the ability to communicate well and exhibit a high level of professionalism.
    • Strong computer skills and experience in technical writing in QA/QC.
    • A high level of initiative, good judgment, and interest in being a facilitator for people and projects.
    • Ability to work both independently and on teams. 


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