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PolyPeptide Group1 week ago

Document Control Coordinator - Torrance

$68,640–$79,040 year

On-site · Torrance, California, United States

Type
Full Time
Level
Mid Level
Education
Associates Degree
Company size
Large

Job Summary

Review manufacturing documentation for accuracy, completeness, and compliance; perform document and change control review activities with minimal supervision; support person-in-plant documentation review, as needed; facilitate GDP corrections for documentation errors; initiate and assist with the closure of process deviations; help establish and maintain systems that support timely documentation review and prioritization; partner with Production Leads and Supervisors to support NC and GDP improvements; communicate with Production management regarding process or performance issues; coordinate with cross-functional teams to support implementation of changes; assist with creating and updating SOPs and forms related to document control processes; provide documentation mentoring and coaching to Production personnel; perform additional duties as assigned.

Required Qualifications

  • Associate or bachelor’s degree in life sciences or related field preferred
  • 2 or more years of experience in a GMP-regulated manufacturing or quality environment
  • Familiarity with cGMP, GDP, and FDA/ICH guidelines
  • Proficiency with Microsoft Office, including Word, Excel, and Outlook
  • Strong attention to detail and commitment to documentation accuracy
  • Strong organizational and analytical skills
  • Ability to prioritize multiple tasks in a fast-paced environment
  • Effective communication skills and ability to work cross-functionally
  • Experience with review of manufacturing documentation and change control
  • Experience with deviations closure
  • SOP creation and form updates related to document control
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$69k – $79k / yr

Document Control Coordinator - Torrance · PolyPeptide Group

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