Sr QC Analyst

at  Biomarin

SENIOR ANALYST QC - MICROBIOLOGY

Exciting opportunity in the QC Microbiology Lab in BioMarin Shanbally. BioMarin has been ranked #01 Best Workplace to Grow Your Career in Ireland in 2024 by LinkedIn.
The QC laboratory supports our end-to-end manufacturing site including Drug Substance and the new Drug Product Facility. This role will be supporting the QC Microbiology Laboratory testing, trouble shooting and trending of data. This is an exciting role that will support Drug Substance and Drug Product facilities as part of the rapidly expanding Shanbally site.
QC Microbiology are a high performing team-based group. The team is dynamic and works cross functionally on site with various other departments supporting routine testing, investigations and project work and providing SME guidance. Members of the team are empowered to make decisions.
A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
The senior QC analyst will report to the QC Microbiology Manager, the primary role of the QC senior analyst is to support the QC analysts working in the lab with trouble shooting, scheduling and investigation write ups. The QC senior analyst will also support cross functional work across the site.

SKILLS/ KNOWLEDGE/ BEHAVIOURS

• Microbiological testing performed by the lab including: EM; Utilities; Bioburden; Endotoxin; Growth Promotion & Biological Indicators
• 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
• Lead investigations and document in quality system
• 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, Engineering, 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.
• Using systems such as Labware LIMS, MODA and Binocs

EDUCATION

B.S. in a scientific discipline with 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
• Experience using quality system such as Veeva
• Experience trouble shooting and investigating out of spec or unexpected results
• Experience with EM programs and contamination control strategies would be an advantage
  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.
  We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law

Please refer the Job description for details