Quality Control Data Reviewer

6 days ago


Indianapolis, Indiana, United States Bristol-Myers Squibb Full time
Transforming Patients' Lives through Science

Bristol Myers Squibb is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that improve patients' lives. We are seeking a highly skilled Quality Control Data Reviewer to join our team in Indianapolis, IN.

Key Responsibilities:
  • Review Quality Control data for accuracy, completeness, and compliance with established procedures and regulatory requirements.
  • Ensure Quality Control data is reviewed in a timely manner.
  • Conduct periodic review and updates of Quality Control Standard Operating Procedures, as necessary.
  • Lead and conduct in-depth investigations following standard operating procedures for out-of-specification results and other quality issues in the quality control laboratory.
  • Document findings of investigations and work with QA and QC management to propose corrective action and corrective training to prevent repeat events.
  • Ensure data integrity throughout data review and investigations as required.
  • Proactively identify opportunities for improvements to both investigations and the data review processes.
Requirements:
  • BS in Chemistry, Biology, Science, or relevant field with five to seven years of experience in pharmaceutical or other cGMP experience.
  • Advanced degrees may be acceptable with less experience, however, direct experience with cGMP technical writing is required.
  • Thorough understanding of cGMP regulations, ICH guidelines, FDA, and other regulatory processes.
  • Experience with injectable pharmaceuticals or radiopharmaceuticals strongly preferred.
  • Ability to multi-task, prioritize work based on multiple workflows, and handle hazardous materials safely.
  • Strong analytical and problem-solving skills, with the ability to work well and communicate effectively with multiple stakeholders.
About Us:

Bristol Myers Squibb is a global biopharmaceutical company that is committed to transforming patients' lives through science. We are a diverse and inclusive organization that values innovation, collaboration, and excellence. Our employees are passionate about making a difference in the lives of patients and are dedicated to delivering high-quality medicines that improve health outcomes.

We are an equal opportunity employer and welcome applications from qualified candidates who share our values and commitment to excellence. If you are a motivated and detail-oriented individual who is passionate about quality and regulatory compliance, we encourage you to apply for this exciting opportunity.



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