Documentation Coordinator

5 days ago


Irvine, California, United States TCWGlobal Full time

Are you looking for a challenging role in quality assurance?

Job Description:

We are seeking a skilled Documentation Coordinator to join our team at TCWGlobal. This is a full-time opportunity with a 9-month contract, offering a competitive salary of $27-$32 per hour and excellent potential for permanent employment.

About the Role:

  • Create, process, and review production batch records following established GDP/GMP processes and procedures.
  • Coordinate with team members to efficiently process Change requests according to ISO /quality/ change management standards.
  • Follow procedures and work instructions to execute production tasks.
  • Complete inventory and quality transactions in SAP Inventory System.
  • Complete required documentation in an accurate and timely manner following Good Documentation Practices (GDP).

Your Qualifications:

  • Associate's degree or equivalent experience.
  • 1-5 years of experience in a regulated industry such as medical device, pharmaceutical, or biotechnology.
  • Experience reviewing, printing batch records, and data entry/entering batch records.
  • Experience in Document Change Control and quality system documents.
  • Must have general knowledge of Good Documentation Practices (GDP).
  • Experience writing, updating, and filing SOPs, NCR's, and CAPAs.'
  • Experience reviewing documents for format, accuracy, and compliance.
  • Experience working with ERP systems such as SAP or similar ERP.
  • Bonus: Experience with Veeva (quality management system software solution).
  • Good oral and written communication skills.
  • Proficient in Microsoft Office suite.
  • Team player, flexible, and quality-minded.

Why Choose Us:

  • We are an equal opportunity employer, committed to diversity and inclusion.
  • We offer a dynamic work environment and opportunities for growth and development.


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