We are seeking a highly motivated and scientifically rigorous individual to join our team as Document Control Manager.   The successful candidate will report to Sr. Director QA and be an integral part of the QA team.  This position offers opportunities to learn and personal and career growth.  The successful candidate will be responsible for overseeing the GxP documentation issued at Translate Bio and its partners.

Primary Responsibilities

  • Write, review and approve Standard Operating Procedures (SOP) and Forms for the organization
  • Ensure all documentation complies with GxP regulations and industry guidelines
  • Plan audit calendar, assist/perform internal/external audits
  • Assure consistency in achieving product quality and compliance across multiple CMOs and CROs
  • Document archival and manage the archival process
  • Assist in build-out, management and continuous improvement of the QMS and SOP system
  • Review and negotiate Quality Agreements; review MSA/SOW to ensure compliance with the QA agreement
  • Review batch records and associated documentation, i.e., deviations, OOSs, investigations, specifications, etc.; lead internal investigations
  • Assist and/or conduct training
  • Manage electronic master of official paper document with secure version controls and limited access
  • Assist in the execution of QA systems to support GxP from both an internal and external perspective
  • Trend and report QA related information (deviations, investigations, CAPA) both internally and from external activities
  • Contribute to the development of new concepts, techniques, and standards
  • Assist with other GXP programs and reviews as needed
  • Oversee the electronic documentation system and assist other team members in its use, as needed

Qualifications

  • BA/BS in Life Sciences
  • Minimum of 5 years’ experience in one of the GxP regulated industries
  • Willingness of learning new things and being a self-motivator as it applies to GxP
  • Ability to work independently and with a multi-disciplinary team – understands quality principles
  • Excellent written and verbal communication skills
  • Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines
  • Ability to travel up to 25% of the time
  • Ability to work effectively/congenially both independently and in a team situation

Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

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