Quality Assurance Document Control Specialist

1 day ago


Bothell, Washington, United States Omni Inclusive Full time
Job Summary

We are seeking a highly skilled Quality Assurance Document Control Specialist to join our team at Omni Inclusive. The successful candidate will be responsible for supporting the cGMP Document Control operations for Client Jump site records management.

Key Responsibilities
  • Receiving and reconciliation of GMP records
  • Management of scanning, archival, and retention of GMP records
  • Supporting the Document Center and ensuring records are readily retrievable
  • Assisting with managing the Document Center Archive room
Requirements
  • Minimum of 5-8 years of relevant document control records management experience in a cGMP/FDA regulated environment
  • Strong communication and customer service skills
  • Experience with Part 11 adherence regarding scanning of records and electronic archiving
  • Strong computer skills with MS Office and Quality Systems
  • Ability to prioritize, manage time well, multi-task, and troubleshoot effectively
Preferred Qualifications
  • Bachelor's degree or equivalent in Library Science or related field
  • Project management skills
  • Strong knowledge of cGMPs and domestic regulatory requirements
What We Offer

Omni Inclusive offers a dynamic and inclusive work environment with opportunities for growth and development. We are committed to providing our employees with the tools and resources they need to succeed.



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