GMP Document Specialist

Employer
TCG GreenChem, Inc.
Location
Ewing, New Jersey
Salary
401K, Medical Insurance, Dental Insurance, Vision Insurance
Closing date
Sep 18, 2021

View more

Field of specialization
Pharmaceutical
Work Function
Administration
Job Type
Full time
You need to sign in or create an account to save a job.

Job Details

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

Apply for GMP Document Specialist

Fields marked with an asterisk (*) are required

Your file must be a .doc, .pdf, .docx, or .rtf. No larger than 1MB
Selected file:
Your communication preferences

When you apply for a job we will send your application to the named employer, who may contact you. By applying for a job listed on C&ENjobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please contact us. All emails will contain a link in the footer to enable you to unsubscribe at any time.

You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert