Quality Assurance Specialist

6 days ago


Lexington, Kentucky, United States Genezen Full time
About Genezen

We are a cutting-edge company in the field of gene therapy, committed to meeting the exacting needs of our clients. Our services include process development, GMP viral vector production, and cell transduction for clinical trials.

Job Summary

We are seeking a Senior Quality Assurance Specialist - Laboratory Operations to support our day-to-day quality operations. The successful candidate will oversee the Quality Management System (QMS), ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities
  1. Review and approve protocols, data, and reports related to method validation and compendial testing.
  2. Provide supportive services to the Facilities Management and Manufacturing groups, including QA review of controlled documents and data review.
  3. Develop and implement quality management systems, ensuring compliance with regulatory requirements and industry standards.
  4. Represent Quality Assurance in technical meetings and special projects, as needed.
  5. Investigate laboratory incidents and develop corrective actions to prevent future occurrences.
Requirements
  • Bachelor's Degree in Life Sciences.
  • 6-8 years of GMP experience.
  • Strong communication and organizational skills.
  • Ability to work well with diverse groups and manage multiple activities with challenging timelines.
Benefits

We offer a comprehensive benefits package, including paid vacation days, paid sick time, 9 observed holidays, and a 401(k) plan with company match.



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