QC Data Reviewer

2 weeks ago


Los Angeles, California, United States Sutro Biopharma Full time
Job Title: QC Data Reviewer

Sutro Biopharma, Inc. is seeking a highly motivated and detail-oriented individual to join our Quality Control team in San Carlos, CA. As a QC Data Reviewer, you will play a critical role in ensuring compliance with Sutro's quality systems, policies, and procedures, as well as US and international regulatory agencies.

Key Responsibilities:
  • Review raw material, release, and in-process testing data to ensure compliance with cGMPs, GDP, FDA, EMA, and ICH guidelines.
  • Collaborate with cross-functional departments to improve analytical data reporting, efficiency, compliance, and quality.
  • Ensure ALCOA+ compliance and accuracy of analytical laboratory data.
  • Review time of use logs on cGMP instrumentation and audit trails on computer systems used to acquire and process data.
  • Provide technical expertise on various analytical equipment, techniques, and methodology.
  • Coordinate and discuss with team members to improve the data review process and provide suggestions for continuous improvement.
Qualifications:
  • Minimum of 4+ years of relevant work experience in Quality Assurance/Data review of QC in a pharmaceutical industry.
  • Experience with MS Programs such as Word, Excel, PowerPoint, Access, and Project.
  • Knowledge of Quality Management Systems and LIMs systems.
  • Excellent oral and written communication skills.
  • Ability to manage multiple priorities and re-prioritize tasks as required.
What We Offer:
  • Competitive salary range: $95,000 - $115,000.
  • Comprehensive benefits package, including health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP, and stock options.
  • Opportunity to work with a dynamic and innovative company that is changing the future of oncology.

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