Manufacturing Quality Systems Specialist - Fill Finish

Seqirus

Holly Springs, NC, US
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Deviation management
Root cause analysis
Capa execution
** Seqirus is seeking a Manufacturing Quality Systems Specialist to support Fill Finish manufacturing operations at their facility in Holly Springs, NC. The role involves managing deviations, leading investigations, and ensuring compliance with cGMP standards while driving continuous improvement in manufacturing processes. **

Job Summary

  • The Manufacturing Quality Systems Specialist supports Fill Finish manufacturing operations by leading investigations, ensuring quality system execution, and providing technical expertise across multiple unit operations.
  • Responsibilities include managing deviations, leading cross-functional investigation teams, developing CAPA plans, and authoring Biological Product Deviation Reports (BPDRs).
  • Benefits include Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

Matching Summary

Match Score: 75

** Seqirus is seeking a Manufacturing Quality Systems Specialist to support Fill Finish manufacturing operations at their facility in Holly Springs, NC. The role involves managing deviations, leading investigations, and ensuring compliance with cGMP standards while driving continuous improvement in manufacturing processes. **

Skills & Requirements

Must-have

  • Deviation management
  • Root cause analysis
  • CAPA execution
  • cGMP environment
  • Technical troubleshooting
  • SOP and batch record writing

Nice-to-have

  • Continuous improvement
  • Cross-functional collaboration
  • Employee development
  • Inclusion and Belonging

Key Requirements

  • Bachelor's degree in Science or Engineering or equivalent experience
  • 1+ year experience in deviation management, RCA, CAPA, change control
  • Experience in a cGMP environment
  • Troubleshooting skills
  • Organizational and time-management skills

Work Rights

Not specified

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