Pharma Quality Control Specialist

4 weeks ago


Kansas City, Missouri, United States KCAS Bio Full time

At KCAS Bio, we're seeking a highly skilled Pharma Quality Control Specialist to join our team. As a key member of our Lab Support group, you'll play a critical role in ensuring the integrity of our data and regulatory compliance.

As a Pharma Quality Control Specialist, you'll be responsible for performing technical, scientific, and compliance reviews of data and documentation generated to support regulated GLP studies. You'll also issue QC review observations, work closely with scientific staff to ensure data integrity, and collect metrics data to monitor the QC reviews and identify process improvements.

Key responsibilities include:

  • Performing technical, scientific, and compliance reviews of data and documentation
  • Issuing QC review observations and working closely with scientific staff
  • Collecting metrics data to monitor the QC reviews and identify process improvements
  • Signing off on data review and verifying data integrity
  • Reviewing reports and documents and identifying any deviations
  • Generating SOPs or policies in applicable areas as required
  • Archiving data as needed

Requirements include a Bachelor's degree in chemical, biological science, or related field, with 5 years of related experience gained from working in biotech, pharmaceutical, CRO/CMO, or similar organizations. Expert knowledge of data generated by laboratory and experience performing data review in a regulated environment are also essential.

We offer a dynamic and supportive work environment, with opportunities for professional growth and development. As a valued member of our team, you'll enjoy company-sponsored events, connect with like-minded employees, and engage as an owner in our stock ownership program.



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