Senior Specialist, QC Microbiology

<p>Working with Us<br/>Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.</p><p></p><p>Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: <a href="https://careers.bms.com/working-with-us" rel="noopener noreferrer" target="_blank">careers.bms.com/working-with-us</a>.</p><p></p><p></p><p>Bristol Myers Squibb Ireland</p><p>Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.</p><p>Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility.  This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio.</p><p>Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.</p><p>BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021.</p><p>For more information about Bristol Myers Squibb, visit us at BMS.com/ie</p><p></p><p>Job Summary</p><p>BMS Cruiserath Biologics is seeking to recruit a QC Microbiology Senior Analyst within QC Microbiology. Reporting to the QC Microbiology Manager, the QC Microbiology Senior Analyst will be responsible for supporting site activities related to Product Testing and Environmental Monitoring, performing testing of samples and laboratory duties in accordance with cGMP regulations.</p><p></p><p><u>Major Duties and Responsibilities</u></p><ul><li><p>Performing QC Environmental Monitoring in Classified Areas (including lot related monitoring), Utility Sampling (Including WFI and Clean Steam), associated testing of samples and completion in a timely and accurate manner of laboratory documentation as directed by the Microbiology Manager.</p></li><li><p>Authoring and reviewing documentation, including SOPs, as required.</p></li><li><p>Perform compendial verification, method transfer/validation, and routine testing of in-process, drug substance and drug product samples in accordance with applicable procedures and cGMP requirements.</p></li><li><p>Performing Bioburden testing on Utility samples, Drug Substance and Raw Materials.</p></li><li><p>Performing Bacterial Endotoxin Testing on Utility samples, Drug Substance and Drug Product.</p></li><li><p>Carrying out the Minute Mouse Virus by PCR and quantitative PCR (qPCR) testing of in-process samples.</p></li><li><p>Performing Growth Promotion testing of media lots entering the laboratory.</p></li><li><p>Delivery of training to QC Microbiology Specialists, documenting training per procedural and cGMP requirements</p></li><li><p>Use scientific principles to assist with microbiological testing methods and the proper use of laboratory equipment.</p></li><li><p>Anticipate and troubleshoot problems.</p></li><li><p>Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements.</p></li><li><p>Author investigation reports and perform root cause analysis.</p></li><li><p>Support document revision, project, CAPA, and investigation/deviation related tasks.</p></li><li><p>Perform assigned tasks within a CAPA, deviation, or project.</p></li><li><p>May lead projects and continuous improvement efforts.</p></li><li><p>Provide support to other departments to ensure qualification and production schedules are adhered to.</p></li><li><p>Ability to work on own initiative with minimum supervision, and as part of a team.</p></li><li><p>Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.</p></li><li><p>Batch paperwork review, and reconciliation of analysis performed in laboratory. Ensuring that any out of specification results are investigated according to site procedures.</p></li><li><p>To ensure a high standard of housekeeping and