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QC Analyst GTAT

San Rafael, CA 94901

Posted: 08/30/2023 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 11377 Pay Rate: $26.00 - $28.00 Remote Friendly:

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.


Role:
  • The GTAT Analyst is responsible for providing support to activities related to lab and equipment management. 
  • The GTAT Analyst is responsible for supporting analytical method development, assisting with troubleshooting work and executing validation and transfer protocols, supporting the writing and reviewing of protocols and reports, supporting training to site QC, Contract Test Labs, and In Country Testing Labs in new techniques and methods.
  • When necessary, the GTAT analyst may provide support in the preparation of regulatory submission documents. 
  • This role may include overtime and shift work.

Skills:
  • Adhere and follow cGMPs guidelines and procedures.
  • Escalate non-compliance concerns to management.
  • Monitor lab equipment for calibration needs, monitoring and tracking of issues related to instrumentation.
  • Support the scheduled testing by ensuring the required reagents and glassware are stocked appropriately.
  • Maintain the laboratory in an inspection-ready state.
  • Become competent in analytical methodologies, including: HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, PCR, etc.
  • Testing of in-process samples, finished product, non-routine samples, packaging and stability, etc. in a cGMP environment as required.
  • Assist with preparation of protocols, summaries, and reports, often for direct submission to pharmaceutical regulatory agencies.
  • Develop, optimize, validate and troubleshoot analytical test methods.
  • Act as technical resource (SME) and train other analysts in areas of expertise.
  • Evaluate results against defined acceptance criteria.
  • Conduct and document laboratory investigations and deviations to completion.
  • Support sample and record management for testing within the group and at CRO/CTO’s.
  • Manage shipment of materials and samples to other BioMarin sites, CRO/CTO’s, or to in-country testing labs.
  • Interact directly with regulatory agency inspectors during audits.
  • Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.
  • Other duties as assigned.

Job Requirements

Education:
  • Bachelor of Science or Bachelor of Arts in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience or Associates of Science with at least 4 years of relevant laboratory 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!