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.
You Belong 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
GMP experience in pharmaceutical/biotech
review of batch documentation
product release
cGMP compliance
regulatory requirements
SOP compliance
Nice-to-have
collaboration with stakeholders
regulatory inspection readiness
continuous improvement
teamwork and communication
Key Requirements
University degree in a relevant scientific discipline