Job Details

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