Senior Quality Control Specialist

4 weeks ago


Cambridge, Massachusetts, United States Editas Medicine Full time
Job Summary

We are seeking a highly skilled Senior QC Analyst to join our Quality team at Editas Medicine. The successful candidate will play a critical role in supporting our product pipeline by overseeing raw materials release testing and in-process and final product release testing.

Key Responsibilities
  • Oversee sampling and storage of QC samples and maintain inventory
  • Maintain laboratory equipment and systems to ensure compliance with industry standards
  • Perform routine and non-routine testing of in-process, final product, and raw material samples
  • Utilize aseptic technique and work with live viruses
  • Generate protocol and reports as required
  • Perform sample management and coordinate shipment of samples to contract testing laboratories
  • Track trend data and aid in compilation of trend reports
  • Complete documentation in accordance with current Good Manufacturing Practices (cGMP)
  • Maintain QC lab and related systems to ensure compliance with industry standards
  • Responsible for change controls, OOS, and deviations as related to QC raw materials
Requirements
  • Master's degree or foreign equivalent in biology, chemistry, or related discipline
  • 3 years of relevant industry experience
  • Demonstrated hands-on experience and organizational skills in a regulated analytical/QC environment
  • Working knowledge of current Good Laboratory Practices (GLP - 21 CFR Part 58), Good Manufacturing Practices (cGMP - 21 CFR Part 210/211), Electronic Records Practices, and Electronic Signatures Practices (21 CFR Part 11)
  • Proficiency in MS Office tools and electronic document and training systems
  • Experience with management and implementation of e-Quality Systems

Please apply online at https://www.editasmedicine.com/careers/ or send resume to abbie.mcgourty@editasmed.com. An EOE.



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