QC Analyst (TEMPORARY)
Location Cork, Ireland ApplyWho 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 coordinating the worldwide movement of our drugs to patients.
QC Analyst - 12 Month Contract
Onsite - Days Role - Shanbally, Cork
Closing date: 12th May 2025
SUMMARY DESCRIPTION
We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
Reporting to the QC Team Leader, the primary role of the QC Analyst is to provide support to internal and external customers by providing quality testing and delivering results in accordance with GMP standards. Ensuring our products are safe for patient use and fit for purpose.
The team is divided into 3 sub-teams QC Analytical; QC Microbiology and QC In-Process. The role could potentially lie within any of these sub-teams depending on experience and requirement. Shift work may be required.
SKILLS/ KNOWLEDGE/ BEHAVIOURS
The role potentially will cover both Analytical and Microbiological testing including but not limited to the following:
- Microbiological testing performed by the lab including: EM; Utilities; Bioburden; Endotoxin; Growth Promotion & BIs
- Analytical testing performed by the lab including: HPLC, SDS, FTIR, UV, plate based assays; capillary electrophoresis
- Testing of finished product, raw materials, packaging and stability
- Perform primary review of QC raw data and trend results
- Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies
- Develop, optimize, validate and troubleshoot analytical test methods
- Draft QC SOPs
- Act as technical resource (SME)and train other analysts in areas of expertise
- Evaluate results against defined acceptance criteria
- Conduct and document laboratory investigations to completion
- Maintain the laboratory in an inspection-ready state
- Interact directly with regulatory agency inspectors during audits
- Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary
- Excellent communication skills both written and verbal
- Customer focus; takes personal responsibility for speed; quality and accuracy of delivery
- Self-motivated and ability to work under pressure
- Team Leadership – active participation team development and continuous improvement including standard work and 5S
- Successful track record in achieving goals as part of a team within a growing, dynamic environment
- Demonstrated adaptability and flexibility to support a growing organisation.
EDUCATION
- B.S. in a scientific discipline
- 3+ years of relevant laboratory experience.
EXPERIENCE
- Ability to work independently and meeting established timelines.
- Comfort with coordinating the activities with other staff members.
- Comfort with working in a team environment
- Knowledge of cGMPs.
CONTACTS
Reports to Quality Control Manager/Team Leader. Interacts with several departments, including but not limited to Manufacturing, Quality Assurance, Maintenance, Engineering, and Manufacturing Sciences.
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.
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.