QC Analyst

QC Analyst -- Shanbally, Ringaskiddy, Cork - Onsite role Days role Monday - Friday 23 month temporary contract 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 incl: EM; Utilities; Bioburden; Endotoxin; Growth Promotion & BIs Anaytical testing performed by the lab incl: 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 with3+ 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. 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, 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.