QA Specialist - GMP Lot Release & Process Improvement

biomarin; Cork; On-site; EUR 45,000 - 65,000; Full time

Job summary

BioMarin is seeking a QA Specialist based in Shanbally, Ringaskiddy, Cork to provide quality oversight for Lot Release and support GMP-compliant manufacturing. The role focuses on ensuring high-quality products, promoting continuous improvement, and working with cross-functional teams to resolve quality issues.

The successful candidate will compile release packs, support packaging operations, author and review SOPs, and actively participate in deviations and CAPA processes to upholdBioMarin's

Qualifications

• Quality input to ensure Lot Release of high-quality products in compliance with GMPs.
• Compilation of Lot Release Packs per SOPs, WIs and related FRMs.
• Support for Secondary Packaging Operations including AQL inspections during routine operations.
• Provide Quality direction and oversight of development and continuous improvement of processes/systems.
• Escalate non-conformances per procedures for compliance, escalation and corrections.

Responsibilities

• Review and release inputs for use in manufacturing as required.
• Write, review and approve Standard Operating Procedures in accordance with BioMarin Policies.
• Coordinate with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control to address issues in real time.
• Assignments may range from routine to more complex projects.

Skills

GMP knowledge

Quality oversight

CAPA

Change Control

Documentation

Job description

BioMarin is seeking a QA Specialist based in Shanbally, Ringaskiddy, Cork to provide quality oversight for Lot Release and support GMP-compliant manufacturing. The role focuses on ensuring high-quality products, promoting continuous improvement, and working with cross-functional teams to resolve quality issues.

The successful candidate will compile release packs, support packaging operations, author and review SOPs, and actively participate in deviations and CAPA processes to upholdBioMarin's