QA Specialist

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

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world‑class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting‑edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Job Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life‑threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

QA Specialist- Shanbally, Ringaskiddy, Cork (Shift Work)

This position within the QA department provides Quality oversight, support and knowledge to activities relating to Quality to meet BioMarin business priorities. The QA Specialist will have proven capability in promoting Quality across cross‑functional teams, to deliver high quality product, ensuring continuous process improvement. The QA Specialist will model the BioMarin Leadership behaviours and understand the principles to drive a culture of continuous improvement building a High‑Performance Organisation.

General QA Specialist Responsibilities

• Provide Quality input and guidance to ensure Lot Release (Final Packed Finished Product) of high quality products in compliance with current Good Manufacturing Practices (GMPs).
• Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs.
• Support for the Secondary Packaging Operations team including performance of AQL inspections during routine operations.
• Provide Quality direction and oversight of the development and continuous improvement of new and existing processes / systems to meet customer needs.
• Exercise judgment to determine appropriate action, ensuring proper escalation when non‑conformances are identified as per applicable procedures for compliance, escalation and corrections.
• Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
• Participates within inter‑departmental and cross‑functional teams, with direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements. Minimising impact to Lot Release operations on site.
• Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
• Review and release inputs for use in manufacturing as required.
• Write, review and approve Standard Operating Procedures in accordance with BioMarin Policies.
• Assignments may range from routine to more complex/non‑routine projects/assignments, where analysis of situation or data requires a review of identifiable factors within the Lot Release operations area.
• Coordinates, plans, implements projects within specified objectives.
• Prioritizes tasks to end

Note

This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.