Specialist, Efvq Systems

Emergent Biosolutions Inc

Lansing, MI, US
Base: $84,500 - $102,000; bonus/equity: annual bon...
On-site
Quality management system expertise
Gmp and data integrity knowledge
Root cause analysis
The Specialist, EFV Quality Systems provides quality systems knowledge and support to ensure departmental compliance, assessing and implementing system level improvements

Job Summary

  • The Specialist, EFV Quality Systems provides quality systems knowledge and support to ensure departmental compliance, assessing and implementing system level improvements.
  • Key responsibilities include managing deviations, CAPA, change control, procedure revisions, audit responses, and quality metrics for EFV quality systems.
  • The role requires a BS in Engineering, Science, or Management with a minimum of 5 years of experience in a biopharmaceutical or related environment, including at least 3 years in EFV support functions.

Matching Summary

The Specialist, EFV Quality Systems provides quality systems knowledge and support to ensure departmental compliance, assessing and implementing system level improvements.

Salary

Base: $84,500 - $102,000; Bonus/Equity: Annual bonus, long-term incentives; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • Quality Management System expertise
  • GMP and data integrity knowledge
  • Root cause analysis
  • CAPA system utilization
  • Change control system management
  • Procedure revision and creation

Nice-to-have

  • Technical writing proficiency
  • Collaboration and communication skills
  • Lean solutions development
  • Partnering with inspection agencies

Key Requirements

  • Minimum 5 years biopharmaceutical experience
  • Minimum 3 years EFV support functions
  • BS in Engineering, Science, or Management
  • Reliability/predictive maintenance knowledge
  • Statistical Process Control knowledge
  • Equipment lifecycle understanding

Work Rights

Not specified

Tailored Resume

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