Specialist Iii, Qa (batch Disposition)

CSL Seqirus

Holly Springs, NC, United States
Batch documentation review
Product release
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.
  • CSL Seqirus is part of CSL, a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.

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

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

Nice-to-have

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

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