Qc Analyst

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need.
We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science.
With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. 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 coordinate the worldwide movement of our drugs to patients. QC Analyst – In-Process 23 Month Contract (Shift) Shift Role - Onsite Only - Shanbally, Cork Closing date Wednesday 11th June 2025 Exciting opening in a newly 5S certified Analytical lab within QC In-Process team at BioMarin.
This role encompasses all in-process testing (analytical and microbial) for the Drug substance and Drug product facilities on site.
The team also supports testing for all incoming raw materials and packaging materials for the pack lines. The team operates on a 4-cycle shift pattern, and members are expected to be flexible, multi-skilled, and empowered to make decisions.
QC In-Process maintains high standards of quality and compliance. Key requirements include high initiative, energy, motivation, and organizational skills. The primary role of the QC Analyst, reporting to the QC Team Lead/Manager, is to support internal customers by performing quality testing and delivering results in accordance with GMP standards. Responsibilities include: Perform primary review of QC raw data and trend resultsPrepare protocols, summaries, and reports for regulatory submissionDraft/Update QC SOPsAct as technical SME and train other analystsEvaluate results against acceptance criteriaConduct and document investigationsMaintain an inspection-ready lab environmentInteract with regulatory inspectors during auditsCoordinate with other departments and contractorsPerform other duties as assignedDesirable Skills: Excellent communication skillsCustomer focus and responsibilitySelf-motivated and able to work under pressureTeam leadership and continuous improvement skillsProven track record in a dynamic environmentAdaptability and flexibilityEducation: BSc in a scientific/engineering discipline with 5+ years (MSc with 3+ years) of relevant cGMP laboratory experience.This description is not exhaustive and may include other duties as assigned. Equal Opportunity Employer/Veterans/Disabled All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.

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