Specialist Iii, Qa (batch Disposition)

Seqirus

Holly Springs, NC, USA
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, one of the largest influenza vaccine providers in the world, and a major contributor to the prevention of influenza globally.

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
  • inclusion and belonging culture
  • collaboration across countries

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter