Manufacturing Quality Systems Specialist - Fill Finish

cslbehring.de

Holly Springs, NC, US
Not specified (likely onsite based on job description context)
Deviation management
Root cause analysis
Capa execution
CSL Seqirus is seeking a Manufacturing Quality Systems Specialist for its Holly Springs, NC facility, focused on supporting Fill Finish manufacturing operations. The role involves ensuring compliance in a cGMP environment, leading investigations, and driving continuous improvement initiatives

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 for root cause analysis, developing CAPA plans, and performing product technical complaint and adverse event investigations.
  • Benefits include Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a Manufacturing Quality Systems Specialist for its Holly Springs, NC facility, focused on supporting Fill Finish manufacturing operations. The role involves ensuring compliance in a cGMP environment, leading investigations, and driving continuous improvement initiatives.

Skills & Requirements

Must-have

  • Deviation management
  • Root cause analysis
  • CAPA execution
  • cGMP environment experience
  • Technical troubleshooting
  • SOP and controlled document writing

Nice-to-have

  • Continuous improvement initiatives
  • Cross-functional team leadership
  • Employee development training
  • Collaboration and communication

Key Requirements

  • Bachelor's degree in Science or Engineering or equivalent experience
  • Minimum 1 year of experience in quality systems
  • Experience in cGMP environment
  • Troubleshooting skills
  • Organizational and time-management skills

Work Rights

Not specified

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