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QA Associate

San Rafael, CA 94901

Posted: 09/05/2025 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 12331 Pay Rate: $25.00 - $27.00 Remote Friendly: Onsite

Job Description

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

Job Requirements

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.

Meet Your Recruiter

Melissa Politron
Recruiter

As a Compass Recruiter, Melissa "Mel" is excited about rediscovering her passion in helping candidates find opportunities that will excel their professional lives and improve their personal lives. She brings a deeply-rooted excitement to the team by understanding the people she works with and finding ways she can support them. Mel's connections with others inspires her to make a difference in the overall well being of her colleagues, candidates and clients alike. 

Outside of Compass, Mel enjoys cooking, dancing and being a mom to her three wonderful boys. She has an obsession with home organization and thoroughly enjoys solving other families' organizational needs. Mel is also very passionate about One Heart Source, a humanitarian organization that combats conditions such as poverty, diseases and illiteracy through education. She participated as a summer volunteer teacher in Tanzania and credits the organization for shaping her into the person she is today. 

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About San Rafael, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Rafael, California area! Nestled in Marin County, San Rafael offers a perfect blend of picturesque landscapes, cultural attractions such as the Marin Veterans' Memorial Auditorium and the Marin History Museum, and a thriving culinary scene with diverse eateries like Sol Food and Terrapin Crossroads. This charming city also boasts easy access to outdoor adventures at China Camp State Park and opportunities to appreciate local art at the Falkirk Cultural Center. Join us in San Rafael, where career growth meets undeniable charm – apply now and discover your next career move in this dynamic region!