Senior Quality Control Specialist
4 weeks ago
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
- 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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