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Associate, QA Frontline

San Rafael, CA 94901

Posted: 04/10/2025 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 12113 Pay Rate: $40.00 - $41.00 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 Company 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

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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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!