Quality Assurance Associate

Compass Consulting; Novato (CA); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading consulting firm is seeking a Quality Assurance professional in Novato, California. The role involves providing QA oversight, ensuring compliance with procedures, and supporting manufacturing operations. Candidates should have a B.S. in a scientific discipline or equivalent experience, along with skills in batch record execution and quality management systems. This entry-level position offers a vital role in ensuring product quality and adherence to regulations.

Responsibilities

• Provide QA oversight and support to manufacturing operations.
• Review executed batch records and associated documents.
• Respond to quality-related incidents and secure documentation for investigations.
• Participate in Root Cause Analysis (RCA).
• Provide cGMP and compliance guidance to personnel.
• Author and review documents in Quality Management Systems.
• Perform area walkthroughs.
• Perform other duties as assigned.

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

Strong analytical and problem-solving skills

Education

B.S. in scientific discipline or equivalent work experience

Job description

Biotechnology & PharmaceuticalResearch & Development | Regulatory Affairs

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

Seniority level

• Entry level

Employment type

• Contract

Job function

• Quality Assurance

Industries

• Biotechnology Research
• Pharmaceutical Manufacturing
• Research Services