QA Specialist: Lot Release & GMP (Contract)

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

Job summary

BioMarin Ireland's Shanbally site is seeking a QA Specialist to provide quality oversight and support for GMP-compliant Lot Release and continuous improvement. The role emphasizes cross-functional collaboration, CAPA handling, and documentation discipline to meet production timelines.

The position focuses on promoting a culture of quality, ensuring deviations are managed, and supporting change control with robust reviews to help BioMarin deliver high-quality therapies.

Qualifications

• Proven capability in promoting Quality across cross-functional teams.
• Experience ensuring Lot Release of GMP-compliant products.
• Ability to write, review and approve SOPs and related documents.
• Escalation and CAPA closure for non-conformances.

Responsibilities

• Provide Quality input to ensure Lot Release (Final Packed Finished Product) of high-quality products per GMPs.
• Compile Lot Release Packs according to SOPs, WIs and FRMs.
• Support Secondary Packaging Operations, including AQL inspections.
• Provide Quality direction for development and improvement of processes/systems.
• Escalate non-conformances and ensure CAPA actions are timely and robust.
• Review Deviations and related CAPAs for closure with proper documentation.
• Collaborate with Manufacturing, Distribution, Maintenance and QC to resolve issues in real time.
• Write, review and approve SOPs in line with BioMarin policies.

Skills

Quality oversight

GMP compliance

Lot Release

CAPA management

Change Control

Deviations

Documentation

Cross-functional

Job description

BioMarin Ireland's Shanbally site is seeking a QA Specialist to provide quality oversight and support for GMP-compliant Lot Release and continuous improvement. The role emphasizes cross-functional collaboration, CAPA handling, and documentation discipline to meet production timelines.

The position focuses on promoting a culture of quality, ensuring deviations are managed, and supporting change control with robust reviews to help BioMarin deliver high-quality therapies.