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QA Operations Specialist

San Rafael, CA 94901

Posted: 10/29/2025 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 12415 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.

Summary:

The Technical Specialist, Quality Assurance Document Control, reporting to the Head of QA Document Control Novato, is responsible for supporting the management of all aspects related to documentation control processes for Quality Assurance and Quality Control and the management of documents in the Veeva Quality Management System. This role requires a working knowledge of Good Manufacturing Practices (GMP), FDA/EMA regulations and will involve collaboration with cross-functional teams to maintain commitment to quality and compliance.

Key Responsibilities:
  • Support the development, implementation, maintenance and improvement of the document control system in accordance with FDA, EMA, and other regulatory agency requirements, ensuring that all quality documents are properly and efficiently managed and accessible.
  • Support the maintenance of QADC hours for Logbooks, corrections, and archive access during business hours with additional hours as needed during audits and inspections.
  • Ensure all quality documents are properly managed, accessible, and adhere to Good Documentation Practices (GDP).
  • Support the management of the lifecycle of quality documents, including archiving and retrieval processes.
  • Support the maintenance of multiple databases such as Logbook trackers, scanned logbooks, notebook trackers, and offsite storage.
  • Support the management of the backlog of documents in the Veeva system, ensuring periodic review and timely lifecycle management of documents, including Documents to Effective (DtE) and Documents to Approval (DtA).
  • Collaborate with cross-functional teams to ensure alignment on documentation practices and support quality initiatives.
  • Ensure right the first time and compliance in all QA Document Control Activities.
  • Ensure documents are returned promptly and maintain efficient flow of physical documents.
  • Ensure audit readiness of QADC areas and act as a key point of contact for audits and inspections.
  • Support the archival of documentation and ensure the QA Document Control room is always audit- ready.
  • Support training team members as needed.
  • Other duties as assigned.

 

Job Requirements

Experience:
  • Minimum of 3 years within the biotechnology or pharmaceutical industry.
  • Extensive knowledge of GMP, FDA, EMA, and other regulatory requirements.
  • Proficient in Veeva EDMS.

Education:
  • BA/BS in life sciences or related field
  • Advance degree desirable but not required.

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!