QA Associate

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

Duties:

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 BioMarin 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

Education:

B.S. in scientific discipline or equivalent work experience.