GMP Document Specialist

Ewing, New Jersey
401K, Medical Insurance, Dental Insurance, Vision Insurance
Jul 19, 2021
Sep 17, 2021
Field of specialization
Work Function
Job Type
Full time

Job Summary

Responsible for documentation and archival of technical, business and regulatory compliance documents of the company.  Maintain the archival file and system up to dates.  Assist compliance managers conducting daily functions.

Principal Duties

  1. Issue control numbers and control copies, and archive documents of technical, business and compliance for the company.  These documents to be distributed per request or archived are including but not limited to the following:
    • Master and executed Batch Production Records and cleaning protocols
    • Documents related to GMP campaigns such as specification and justification memo
    • Technical transfer documents such as Laboratory Procedure Transfer Document (LPTD), meeting minutes generated in process safety and operability review meeting
    • Non-conformance investigation reports and variance documents
    • Validation documents, engineering drawings and documents related to GMP facility and equipment
    • Training procedures and records
    • Technical and business operational procedures
    • Log sheets / books, material inventory documents
    • Notebooks and auxiliary binders
  2. Examine documents to determine whether they are in compliance with SOPs and TCG GreenChem policy, and request for corrective actions to be taken prior to archival
  3. Maintain the archival system up to date; logically categorize and systematically file for easy access and retrieval
  4. Assist company personnel in retrieving data
  5. Assist compliance managers in running daily activities
  6. Write and update versions of operation protocols and SOPs, provide trainings to company personnel
  7. Communicate to company personnel regarding documentation requirements
  8. Perform activities as per SOPs and TCG GreenChem policy

Job Qualifications

  • BS or MS and 5+ years relevant working experience preferably in API development and scale up / manufacturing under cGMP environment
  • Demonstrated essential knowledge and understanding of cGMP requirement, and practices applicable to early API development process
  • Able to organize, prioritize and plan work
  • Have strong sense of time management and urgency
  • Must be detail oriented and able to work within defined timeline
  • Must be able to work independently in a team environment, and to provide training and guidance to personnel of various backgrounds
  • Able to write investigation report, protocol and memo related to cGMP matters
  • Must possess good computational and interpersonal communication skills
  • cGMP audit experience is a plus

Skills Required

  • Excellent verbal and written communication
  • Critical thinking
  • Problem solving
  • Active listening
  • Out-of-the-box thinking
  • Proactivity
  • Knowledge of regulatory requirements

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