Associate, QA Frontline

2 weeks ago

novato, United States TalentBurst Full time
Associate, QA Frontline
Novato, CA
12 Months
Shift Details:
Alternate Wed, Thurs-Sat 1800-0700
Alternate Wed, Sun-Tues 1800-0700
Description:
  • Provide on-the-floor QA oversight and support to manufacturing operations
  • Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations
  • Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations
  • Represent QA in support of deviations including active participation in Root Cause Analysis (RCA)
  • Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel
  • Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with Client policies
  • Perform area walkthroughs
  • Perform other duties and projects as assigned by management
Skills:
  • Prior batch record execution or review experience
  • Prior experience in investigation, change control, other Quality Management Systems (QMS)
  • Working knowledge of cGMPs
  • Excellent written and verbal communication and interpersonal skills
  • Must display strong analytical and problem-solving skills
  • Manufacturing and Manufacturing Sciences experience preferred.
#TB_PH

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