Specialist Iii, Qa (batch Disposition)

CSL Limited

Holly Springs, North Carolina, US
Cgmp compliance
Batch documentation review
Product release
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.
  • Seqirus is one of the world leaders in the production of the influenza vaccine, operating as one integrated global company.
  • CSL is an Equal Opportunity Employer and emphasizes Inclusion and Belonging as core to its mission and culture.

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

  • cGMP compliance
  • batch documentation review
  • product release
  • regulatory requirements
  • SOP adherence
  • stakeholder communication

Nice-to-have

  • influenza science expertise
  • pandemic preparedness
  • inclusion and belonging
  • collaboration

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