• QA Documentation Specialist

    Job Locations US-MA-Lexington
    Job ID
  • Overview

    The successful candidate will be responsible to assure coordination of activities and the development/improvement related to documentation systems at the Agenus facility in Lexington.  Maintains signature card file and ensures cards are updated and consistent with organizational charts.  Responsible for issuance of batch and solution lot records.                                                                                                  


    • Maintain a validated electronic document management system compliant with regulatory, and quality requirements.
    • Manage Document Control support including but not limited to processing, publishing, and distributing controlled documents.
    • Collaborate with cross-functional departments to ensure timely implementation of document change requests.
    • Ensure timely release of documentation for production process and associated activities.
    • Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures.
    • Maintain records management system including secure storage, retrieval, retention and destruction.
    • Within Master Control, develop and design document templates for SOPs, Test Methods, Specifications, Reports, and Protocols preferably in eCTD format. Evaluate capabilities of Master Control and assess if improvements are necessary to maintain compliance.
    • Supports audits (internal, external, third party) in order to verify that regulatory and quality requirements have been met.
    • Support establishment of departmental training matrices.
    • Support implementation and maintenance of an electronic training system compliant with regulatory, and quality requirements.
    • Provide new hires an introduction to eQMS as part of New Employee Orientation.


    • The candidate should have at least a BS/BA  and a  minimum of 2 years experience in a pharmaceutical or medical device company.


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