What are the responsibilities and job description for the Quality Assurance Associate position at Compass Consulting?
About the Company: 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.
About the Role: This role involves providing quality assurance oversight and support to manufacturing operations, ensuring compliance with established procedures and regulations.
Responsibilities:
- 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
Qualifications:
- B.S. in scientific discipline or equivalent work experience.
Required 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
Preferred Skills:
- Manufacturing and Manufacturing Sciences experience preferred
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