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Manpower Engineering is looking for a QA Document Control Specialist. This is a contract opportunity. Details as follow:

Job Title: QA Document Control Specialist

Description/Comment: GMP experience required - at least 6 months to a year AND proficient in MS WORD. Responsible for performing various administrative tasks in support of the Quality Assurance department and its clients including but not limited to SOP review, supporting the QA Archive, Electronic Document Management System (EDMS), and GxP Training Program. Participates in independent and team projects as defined by the department manager.

Essential Functions:

  • Facilitates the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.) by functioning as a document workflow coordinator.
  • Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, distributions and archiving.
  • Provides day-to-day support of the electronic document management system (EDMS), and operational controls to maintain the validated state (compliance with 21 CFR Part 11)
  • Collaborates with team to identify opportunities for process improvement in the Document Control program and works cross functionally to implement, as appropriate.
  • May assist with end-user training for new users of the EDMS and document control business processes.
  • Participates in Standard Operating Procedures generation and review.
  • Provides day-to-day operation support for client groups (e.g. scheduling, reporting, records archiving)
  • Assist with metrics generation of monthly periodic reviews for Quality management Supports audits and/or regulatory inspections.
  • Other duties may be assigned. Facilitates the archival of GMP documentation and records:
  • Prepares and inspects documents for scanning operations, scans and re-assembles documents
  • Conducts quality assurance tests to ensure images meet quality standards; appends or correct images in response to quality assurance findings.
  • Uploads electronic records into the Electronic Document Management System (EDMS).
  • Files and organizes archival records and develops classification systems to facilitate access to archived records.
  • Coordinates the transfer of records with document storage facilities; manages record classifications and storage location in the Record Management System (RMS).
  • Ensures records are maintained according to regulatory requirements including quality checks.
  • Supports and participates in internal and external audits as requested. Provides operational support to the GMP Training Program, as needed:
  • Maintain employee training files/database or LMS
  • Processes training files by reviewing data for deficiencies; resolving discrepancies by using standard procedures or returning incomplete training files to the team leader for resolution.
  • May assist with end-user training of the LMS and user creation
  • Ensures employee training documentation is in accordance with regulatory requirements. others.
  • Demonstrates attention to detail.


Recruiter: Cristal Smith


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