Associate, QA Frontline
46 Galli Road Novato, CA 94949 US
Job Description
Shift Details: Alternate Sat, Sun-Tues 1800-0700; Please note that while this role primarily involves night and weekend shift hours, there may be occasions where the need for flexibilityis required, as shift hours canvarydepending on operational demands.
- 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 company policies
- Perform area walkthroughs
- Perform other duties and projects as assigned by management
- B.S. in scientific discipline or equivalent work experience.
- -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
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