QA Associate

Job Description

Alternate Saturdays, Sunday - Tuesday 1800 -0700

Please note that while this role primarily involves night and weekend shift hours, there may be occasions where the need for flexibility?is required, as shift hours can?vary?depending 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

Requirements :

B.S. in scientific discipline or equivalent work experience. -Prior batch record execution or review experience

Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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