Quality Assurance Associate

3 days ago Be among the first 25 applicants

This range is provided by Talent Burst, an Inc 5000 company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$30.00/hr - $40.00/hr

Duration: 12+ Months Contract

• Alternate Saturday, Sunday – Tuesday, 06:00 PM – 07:00 AM

• B.S. in scientific discipline or equivalent work experience.
• Prior batch record execution or review experience.
• Prior experience in investigation, change control, and other Quality Management Systems (QMS).
• Working knowledge of cGMPs.
• Excellent written and verbal communication and interpersonal skills.
• Strong analytical and problem-solving skills.
• Manufacturing and Manufacturing Sciences experience preferred.

• 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 Bio Marin policies.
• Perform area walkthroughs.
• Perform other duties and projects as assigned by management.

• Mid-Senior level

• Contract

• Science, Research, and Engineering

• Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Talent Burst, an Inc 5000 company by 2x.