QC Analyst - Microbiology - Shanbally, Ringaskiddy, Cork 23 Month Contract - Onsite role Closing date: 16th August 2024 Exciting opening in QC Microbiology team at BioMarin. This role is supporting both Drug Substance and Drug Product facilities based onsite. The scope of the team includes environmental monitoring, growth promotion, water sampling and trending, biological indicator testing, bioburden, trend reporting of the control of the clean rooms onsite. Working closely with the new sterility testing team onsite and other teams onsite. QC Microbiology is a high-performing, team-based group, where colleagues are flexible, multi-skilled and empowered to make decisions. Microbiology operates to an extremely high standard of quality and compliance. A high level of initiative, energy and motivation are key role requirements, as well as organizational skills. Reporting to the QC Microbiology Team Lead this QC Microbiology analyst's role is to provide testing and SME knowledge in accordance with GMP standards. Responsibilities Include: Microbiological testing performed by the lab incl: EM; Utilities; Bioburden; Growth Promotion & BIs Supporting activities in Drug Product - including media fills Supporting method development and validation Perform primary review of QC raw data and trend results Develop, optimize, validate and troubleshoot 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, 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 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 Report writing on a routine basis EDUCATION B.S. in a scientific discipline with 2+ 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 in Microbiology Lab an advantage 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, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. 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. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.