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Documentation Specialist

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 05/21/2018 Job Number: JN -052018-21640
Documentation Specialist

Responsibilities:
  • This position is responsible for managing the document and change control process, document support for development and design history files, and management of supplier files and training records.
  • Manage Document Control process. Assign document numbers, part numbers, lot numbers to ensure compliance with document numbering structure.
  • Coordinate QA Document Change Orders (DCOs). Provide guidance to document initiators in document formatting according to the templates and General Operating Procedures (GOPs). Format documents according to templates.
  • Set up training records for new employees and manage training matrix. Collaborate with supervisors to ensure training records are updated. Coordinate training.
  • Oversee supplier records, supplier evaluations, and supplier reviews. Maintain Approved Supplier List.
  • Oversee CAPA, Nonconformance and Deviation records. Maintain records and logs.
  • Manage Design History File with Product Development. Manage DHF index. Support Development in creation and maintenance of BOMs, part specifications, and manufacturing drawings and instructions.
  • Perform review and approval of production records, including incoming material and in-house batch records.
  • Ensure quality records and reports are reviewed, organized and filed.
  • Gather and publish metrics for management review.
  • Support internal and external audits.
Experience Required:
  • Bachelor s degree in Life Science, Engineering, Computer Sciences or another related discipline or comparable experience.
  • Minimum of 2-5 years related experience in document control, quality records management, records review and approval.
  • Strong interpersonal skills, ability to work independently and in teams.
  • Experience with US FDA regulations for medical devices, plus international preferred.
  • Experience with IVD products, following applicable guidelines, is preferred.

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