Specialist Iii, Qa (batch Disposition)

Seqirus

Holly Springs, NC, US
Review of batch documentation
Release of commercial products
Cgmp compliance
The QA Specialist supports review of batch documentation and release of internal and external commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements

Job Summary

  • The QA Specialist supports review of batch documentation and release of internal and external commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements.
  • Responsible for certification and/or rejection of incoming material, manufactured material, including intermediates, buffers, virus seed, monobulk and drug product in compliance with applicable licenses and legal requirements.
  • At CSL, Inclusion and Belonging is at the core of our mission and who we are.

Matching Summary

The QA Specialist supports review of batch documentation and release of internal and external commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements.

Skills & Requirements

Must-have

  • review of batch documentation
  • release of commercial products
  • cGMP compliance
  • SOP compliance
  • regulatory requirements
  • identify non-compliances

Nice-to-have

  • collaboration with stakeholders
  • knowledge of regulatory trends
  • site readiness for inspections
  • inclusion and belonging culture

Key Requirements

  • University degree in scientific discipline
  • 3+ years GMP experience
  • Knowledge of cGMP principles
  • Knowledge of FDA and EMA requirements

Work Rights

Not specified

Tailored Resume

Cover Letter