Alternate Saturdays, Sunday - Tuesday 6pm - 7am
-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
Requirements
- 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
Seniority level
- Associate
Employment type
- Contract
Job function
- Quality Assurance and Science
Industries
- Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing