cGMP Records Management Associate

4 days ago


Bothell, Washington, United States Omni Inclusive Full time
cGMP Records Management Associate Job Description

We are seeking a highly skilled cGMP Records Management Associate to join our team at Omni Inclusive. This is a full-time contract position that will be working with us for 12 months until December 2024.

The estimated salary for this position is $90,000 per year.

In this role, you will support the cGMP Document Control operations for Client Jump site records management, including receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records.

You will need a strong understanding of Part 11 adherence regarding scanning of records and electronic archiving, as well as proficiency in MS Office and Quality Systems.

The ideal candidate will have a Bachelor's degree or equivalent in Library Science or a related field, along with at least 5-8 years of experience in document control records management in a cGMP/FDA regulated environment.

Job Responsibilities:
  • Support the cGMP Document Control operations for Client Jump site records management.
  • Manage the receipt and reconciliation of GMP records.
  • Implement effective document management processes.
Requirements:
  • Bachelor's degree or equivalent in Library Science or a related field.
  • At least 5-8 years of experience in document control records management in a cGMP/FDA regulated environment.
  • Strong understanding of Part 11 adherence regarding scanning of records and electronic archiving.
  • Proficiency in MS Office and Quality Systems.


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