QC Analyst

About BioMarin

BioMarin is a biotechnology company devoted to rare diseases and genetically defined conditions. Since its founding in 1997, the organisation has developed therapies that help address conditions such as achondroplasia, PKU (phenylketonuria), CLN2/Batten disease, and several forms of MPS (mucopolysaccharidosis). Following the Amicus acquisition, its portfolio also includes treatments for Fabry disease and Pompe disease, broadening its reach to more people living with rare genetic disorders.

The company’s progress is driven by a strong focus on scientific excellence, a deep understanding of patient needs, robust manufacturing capability, and a committed global workforce.

About Technical Operations

BioMarin’s Technical Operations function is responsible for producing medicines for clinical trials and for scaling up commercial supply. The team includes engineers, technicians, scientists, and support staff who develop and maintain manufacturing processes and facilities, ensure quality assurance and quality control standards are met, source required goods and services, and support the movement of medicines worldwide.

Role Overview

BioMarin is hiring a QC Analyst for its QC In Process Control team at the Shanbally, Cork site. This is a shift-based position on a 4-cycle rotation within a newly 5S-certified analytical laboratory. The role offers exposure to both drug substance and drug product manufacturing in a fast-moving, highly regulated GMP setting.

The QC In Process team carries out analytical and microbiological testing that supports site manufacturing operations. The team also tests incoming raw materials and packaging materials to help downstream packing activities run smoothly.

Because testing is required around the clock, this position is part of a 4-cycle shift structure that supports continuous manufacturing operations.

The team is high-performing, collaborative, and adaptable, with a strong emphasis on quality, compliance, safety, continuous improvement, standard work, and 5S.

The role calls for initiative, energy, motivation, strong organisational ability, and the confidence to perform effectively in a dynamic manufacturing environment.

Key Responsibilities

• Carry out first-pass review of QC raw data and trend outputs.
• Prepare protocols, summaries, and reports, including documentation that is submitted directly to regulatory authorities.
• Write and revise QC standard operating procedures.
• Serve as a technical expert in designated areas and provide training and guidance to fellow analysts.
• Assess analytical and microbiological findings against established acceptance limits.
• Lead and document laboratory investigations through to closure.
• Keep the laboratory continuously ready for audits and inspections.
• Engage directly with regulatory inspectors during audits and site inspections.
• Work with Manufacturing, Quality Assurance, Facilities, and external contractors when needed.
• Complete additional duties as assigned.

Skills and Attributes

• Strong written and spoken communication abilities.
• Customer-oriented mindset with personal ownership of speed, quality, and accuracy.
• Ability to stay effective under pressure in a fast-paced setting.
• Collaborative approach with active involvement in team growth, standard work, and 5S.
• Track record of meeting targets as part of a high-performing team in a growing organisation.
• Flexibility and adaptability in an evolving operational environment.

Education and Experience

• BSc in a scientific or engineering discipline plus at least 5 years of relevant cGMP laboratory experience; or
• MSc plus at least 3 years of relevant cGMP laboratory experience.

Additional Information

Closing date: 29 June 2026.

This job description is intended as a general guide and is not exhaustive. Duties may be expanded or adjusted as required.

Equal Opportunity

BioMarin is an equal opportunity employer. All qualified applicants will be considered without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.