QA Specialist – GMP Lot Release & Process Improvement

BioMarin Pharmaceutical Inc.; Cork; On-site; EUR 42,000 - 56,000; Full time

Job summary

BioMarin Pharmaceutical Inc. in Ringaskiddy, Cork, seeks a QA Specialist for a 12-month contract in Shanbally. The role focuses on quality oversight to ensure GMP-compliant lot release of final products and continuous process improvement.

You will compile Lot Release packs, support secondary packaging, and provide QA direction on changes, deviations and CAPAs, collaborating with Manufacturing, Supply, Distribution, Maintenance and Quality Control to meet deadlines.

Qualifications

• Quality oversight to meet business priorities.
• Promote a culture of continuous improvement within QA.

Responsibilities

• Provide QA input to Lot Release (Final Packed Finished Product) per GMPs.
• Compile Lot Release Packs per SOPs/WIs/FRMs.
• Support Secondary Packaging Operations including AQL inspections.
• Provide QA direction for development/improvement of processes/systems.
• Escalate non-conformances and manage corrective actions.

Skills

Quality assurance

GMP compliance

Lot Release

CAPA

Change control

Deviations

SOPs

Cross-functional teamwork

Job description

BioMarin Pharmaceutical Inc. in Ringaskiddy, Cork, seeks a QA Specialist for a 12-month contract in Shanbally. The role focuses on quality oversight to ensure GMP-compliant lot release of final products and continuous process improvement.

You will compile Lot Release packs, support secondary packaging, and provide QA direction on changes, deviations and CAPAs, collaborating with Manufacturing, Supply, Distribution, Maintenance and Quality Control to meet deadlines.