QC Analyst
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.
Location: BioMarin Shanbally, Cork - QC In Process | 4 Cycle Shift Pattern
An exciting opportunity has arisen for a QC Analyst to join BioMarin's QC In Process Control team, based in a newly 5S certified analytical laboratory. This role offers excellent exposure across both Drug Substance and Drug Product manufacturing, in a fast paced, highly compliant GMP environment.
The QC In Process team delivers comprehensive in process analytical and microbiological testing, supporting manufacturing operations across the site. In addition, the team performs testing of incoming raw materials and packaging materials to support downstream pack line activities.
Due to the critical, around the clock nature of in process testing, this role is part of a4 cycleshift team, supporting continuous manufacturing operations.
QC In Process is a high performing,team basedgroup, where colleagues are flexible, multi skilled, and empowered to make decisions. The team operates to an exceptionally high standard of quality, compliance, and safety, with a strong focus on continuous improvement, standard work, and 5S.
This role requires a high level of initiative, energy, and motivation, together with strong organisational skills and the ability to thrive in a dynamic manufacturing environment.
Role Responsibilities
Reporting to the QC Team Lead, the QC Analyst is responsible for supporting internal customers by delivering high quality, compliant test results in accordance with GMP standards.
Key Responsibilities:
Prepare protocols, summaries, and reports, including documents submitted directly to pharmaceutical regulatory agencies
Draft and update QC Standard Operating Procedures (SOPs)
Act as a technical subject matter expert (SME) and provide training and support to other analysts in areas of expertise
Evaluate analytical and microbiological results against defined acceptance criteria
Conduct and document laboratory investigations through to completion
Maintain the laboratory in a constant state of audit and inspection readiness
Interact directly with regulatory agency inspectors during audits and inspections
Interface with other BioMarin functions including Manufacturing, Quality Assurance, Facilities, and external contractors as required
Other duties as assigned
Strong customer focus, with personal accountability for speed, quality, and accuracy of delivery
Self motivated, with the ability to work under pressure in a fast paced environment
Team oriented, with active participation in team development and continuous improvement, including standard work and 5S
Demonstrated success in achieving goals as part of a high performing team in a growing organisation
Proven adaptability and flexibility to support an evolving operational environment
Education and Experience
BSc in a scientific or engineering discipline with 5+ years of relevant cGMP laboratory experience
or
MSc with 3+ years of relevant cGMP laboratory experience
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.
