QC Specialist, Materials Management, Incoming Components

<p><b>Working with Us</b><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. 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"><span><span><span><span><span><span><span>careers.bms.com/working-with-us</span></span></span></span></span></span></span></a>.</p><p></p><p></p><p><b>Bristol Myers Squibb Ireland</b></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. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been <span>awarded “Biopharma</span> 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><b>Position Summary</b></p><p>Cruiserath Biologics is currently seeking a Biologics QC Senior Specialist – QC Materials Management Services Team Lead to oversee QC testing and support activities within the QC laboratory. Reporting to the QC Materials Manager, Incoming Components, the Senior Specialist will play a key role in supporting the QC laboratory both directly and indirectly.</p><p></p><p>Key responsibilities will include:</p><p></p><p><b>Manage Operations</b></p><ul><li><p>Assisting with qualification of laboratory instruments.</p></li><li><p>Participate in regulatory audits as required.</p></li><li><p>Performing routine lab analysis, data analysis, assist in the investigation of OOS results, perform trending analysis and writing investigation reports and event reviews.</p></li><li><p>Execute and assist in technical transfer and co-validation activities.</p></li><li><p>Perform instrument performance checks and calibration.</p></li><li><p>Participate in troubleshooting complex testing and instrumentation issues.</p></li><li><p>Testing of materials/components to meet attainment and release metrics.</p></li><li><p>Support the QC Laboratory with the testing and release of QC samples.</p></li></ul><p></p><p><b>Manage Information</b></p><ul><li><p>Assisting in creating, updating and issuing documentation, including SOP’s, as required.</p></li><li><p>Accurately documenting laboratory work adhering to best practice documentation behaviours and GMP level of quality.</p></li><li><p>Complete peer review of documented lab results, logbooks, and associated documents to ensure testing has been completed in compliance with procedures.</p></li></ul><p></p><p><b>Safety</b></p><ul><li><p>Prioritise safety in every aspect of the role.</p></li><li><p>Engage fully with site safety guidelines and culture.</p></li><li><p>Lead by example in promoting and displaying good safety behaviours.</p></li></ul><p></p><p><b>Teamwork</b></p><ul><li><p>Succeed as part of a laboratory-based team, to achieve team goals for testing and release of QC Samples.</p></li><li><p>Participate in cross functional teams to deliver department and site goals.</p></li><li><p>Provide support to other departments to ensure site schedules are adhered to.</p></li><li><p>Development</p></li><li><p>Participate in and perform training where required.</p></li><li><p>Participate in and perform all team based activities to meet site demands.</p></li></ul><p></p><p><b>Housekeeping</b></p><ul><li><p>Maintain lab to highest standards to ensure all assigned areas are maintained by designees.</p></li><li><p>Perform all other activities as indicated by Supervisor.</p></li></ul><p></p><p><b>Designee Responsibilities </b></p><p>The designee can act on behalf or in place of the Immediate Supervisor/Manag