Document Control Specialist

Document Control Specialist

16 Jun 2024
Maryland, Gaithersburg, 20899 Gaithersburg USA

Document Control Specialist

Vacancy expired!



You will be responsible for the maintenance and management of controlled documents and records and ensuring records are organized and maintained and support the implementation of quality systems in compliance with regulations and company policies. Overall, your responsible for supporting the maintenance of quality systems and processes. The position will also provide administrative support to the quality assurance team.

Essential Functions


  • Will work directly with Operations, R & D, Clinical and Vendors to process, revise, issue, track, and archive GMP and Google Cloud Platform controlled documents in the electronic Document Management System (DMS).

  • Manage the routing, review, approval, distribution and archival of new and revised standard operating procedures (SOPs), manufacturing batch records, Quality Control test methods/specifications and other related controlled documents in the DMS to support Operations and Quality departments.

  • Oversee and manage all controlled document training and the Quality System Training records

  • Provide status updates and reminders when necessary, regarding document status for new, revised and those under annual review.

  • Support and maintain all Quality System documentation within the DMS for GMP and Google Cloud Platform compliance.

  • Support regulatory chronologies and source document files.


Required Education and Experience


  • Bachelor's Degree preferred.

  • Minimum 1 year of hands-on experience in performing Document Control and archival functions in the pharmaceutical/Biotech industry.

  • Must have excellent computer skills and be proficient in Microsoft Office tools such as Word, Excel, Adobe Acrobat.





Benefits:


  • Health insurance

  • Casual Dress code

  • 401k match




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EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.










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Job Details

  • ID
    JC15511702
  • State
  • City
  • Job type
    Contract
  • Salary
    $25. - $2640. per hour
  • Hiring Company
    Real Staffing
  • Date
    2021-06-16
  • Deadline
    2021-08-15
  • Category

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