Group Leader, Manufacturing Quality Assurance

Catalent

Not specified; competitive medical benefits; 401k ...
Fda regulations and gxp compliance
Batch record review and product release
Investigation and capa management
The role provides leadership and day-to-day oversight for QA activities supporting commercial manufacturing operations at Catalent

Job Summary

  • The role provides leadership and day-to-day oversight for QA activities supporting commercial manufacturing operations at Catalent.
  • Candidates will guide a team responsible for document review, batch record evaluation, product release, and ensuring compliance with FDA regulations.
  • Catalent offers competitive medical benefits, 401K, 152 hours PTO plus 8 paid holidays, and opportunities to work on continuous improvement processes.

Matching Summary

The role provides leadership and day-to-day oversight for QA activities supporting commercial manufacturing operations at Catalent.

Salary

Not specified; Competitive medical benefits; 401K included

Skills & Requirements

Must-have

  • FDA regulations and GxP compliance
  • Batch record review and product release
  • Investigation and CAPA management
  • Team leadership and guidance
  • Root cause analysis participation

Nice-to-have

  • Continuous improvement drive
  • Customer discussion leadership
  • Dynamic fast-paced environment
  • EDMS document system proficiency

Key Requirements

  • BS/BA in related field with 2+ years experience
  • Associate degree with 5+ years experience
  • Demonstrated team leadership capability
  • Experience solving routine and non-routine quality issues

Work Rights

Not specified

Tailored Resume

Cover Letter