QA Specialist: Biotech Lot Release & Process Quality

BioMarin Pharmaceutical Inc.; Ireland; On-site; EUR 45,000 - 65,000; Full time

Job summary

BioMarin Pharmaceutical Inc. is seeking a QA Specialist to provide quality oversight across cross-functional teams and ensure compliance with GMP standards.

The role focuses on Lot Release, change control, deviations, and continuous process improvement at the Shanbally site in Cork, Ireland. The successful candidate will promote a culture of quality, lead CAPA actions, and collaborate with Manufacturing, Quality Control, and other functions to deliver high-quality products for patients with rare

Qualifications

• Quality oversight across cross-functional teams.
• Experience with GMPs and regulatory expectations.
• Ability to review and approve deviations and CAPAs.

Responsibilities

• Provide Quality input to Lot Release (Final Packed Finished Product) in GMP compliance.
• Compile Lot Release Packs per SOPs and FRMs.
• Support Secondary Packaging Ops including AQL inspections.
• Direct and oversee development and improvement of processes/systems.
• Escalate non-conformances per procedures.
• Review Deviations and CAPA-closure actions for compliance.
• Collaborate with Manufacturing, Supply & Distribution, Maintenance, Metrology and QC to resolve issues in real time.

Skills

Quality oversight

GMP compliance

CAPA management

Change Control

Deviation management

Lot Release

Job description

BioMarin Pharmaceutical Inc. is seeking a QA Specialist to provide quality oversight across cross-functional teams and ensure compliance with GMP standards.

The role focuses on Lot Release, change control, deviations, and continuous process improvement at the Shanbally site in Cork, Ireland. The successful candidate will promote a culture of quality, lead CAPA actions, and collaborate with Manufacturing, Quality Control, and other functions to deliver high-quality products for patients with rare