QC Analyst - 4 Cycle Shift

About the Company

BioMarin is a biotechnology company dedicated to rare diseases and genetically defined conditions. Since 1997, the organization has worked to create treatments that can meaningfully improve the lives of patients and their families, with therapies spanning conditions such as achondroplasia, PKU, CLN2, and multiple types of MPS. Following the Amicus acquisition, its portfolio also includes treatments for Fabry and Pompe disease.

The company’s success is built on scientific depth, patient focus, operational excellence, and advanced manufacturing capability. Its global teams work together to deliver innovative therapies around the world.

About Technical Operations

The Technical Operations function develops medicines for clinical trials and commercial supply. The team includes engineers, technicians, scientists, and support staff who manage manufacturing processes and sites, provide quality assurance and quality control, and coordinate the sourcing and global movement of materials and products needed to support patients.

Role Overview

This opening is for a QC Analyst within the In-Process Control team at BioMarin’s Cork site. The position is based in a newly 5S-certified analytical laboratory and provides exposure to both Drug Substance and Drug Product manufacturing in a highly regulated GMP setting.

The team performs in-process analytical and microbiological testing, supports manufacturing across the site, and also tests incoming raw materials and packaging materials for pack line operations. Because the work supports continuous manufacturing and around-the-clock testing, the role follows a 4-cycle shift pattern.

The environment is collaborative, flexible, and highly quality-driven, with strong emphasis on standard work, continuous improvement, safety, and 5S. The role suits someone who is motivated, organized, and able to perform effectively in a fast-moving manufacturing environment.

Key Responsibilities

• Carry out first-level review of QC raw data and trend outputs.
• Compile protocols, summaries, and reports, including documents that are submitted to pharmaceutical regulatory authorities.
• Write and revise QC standard operating procedures.
• Serve as a technical expert in assigned areas and help train and guide other analysts.
• Assess analytical and microbiological findings against defined acceptance limits.
• Run and complete laboratory investigations, documenting findings through closure.
• Keep the lab continuously ready for audits and inspections.
• Communicate directly with regulatory inspectors during audits and site inspections.
• Work with Manufacturing, Quality Assurance, Facilities, and external contractors as needed.
• Complete additional tasks as assigned.

Skills and Attributes

• Clear written and spoken communication.
• Strong customer orientation with ownership of speed, quality, and accuracy.
• Ability to stay effective under pressure in a busy environment.
• Collaborative mindset with active involvement in team growth and continuous improvement practices such as standard work and 5S.
• Track record of contributing to results in a high-performing and expanding organization.
• Flexibility and adaptability in a changing operational setting.

Education and Experience

A BSc in a scientific or engineering discipline with 5+ years of relevant cGMP laboratory experience, or an MSc with 3+ years of relevant cGMP laboratory experience.

Additional Information

The job description is intended to outline the general nature of the role and is not exhaustive. Other duties may be added or assigned as needed.

Equal Opportunity

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