Senior Specialist, QC 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 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"><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></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.</p><p>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></p><p>For more information about Bristol Myers Squibb, visit us at BMS.com/ie</p><p></p><p><b>The Role</b></p><p></p><p>Cruiserath Biologics are seeking to recruit on a permanent contract, Senior Specialist, QC Materials Management with responsibilities for QC testing and support activities in the QC laboratory. Reporting to the QC materials Manager, Incoming Components, the QC Senior Specialist provide support directly and indirectly to the QC laboratory.</p><p></p><p>NOTE: Shift work may be required as part of this role.</p><p></p><p><b>Key Duties and Responsibilities:</b></p><p></p><p><b>Manage Operations</b></p><ul><li>Assisting with qualification of laboratory instruments.</li><li>Participate in regulatory audits as required.</li><li>Performing routine data analysis, assist in the investigation of OOS results, perform trending analysis and writing investigation reports and event reviews.</li><li>Execute and assist in technical transfer and co-validation activities.</li><li>Perform instrument performance checks and calibration.</li><li>Participate in troubleshooting complex testing and instrumentation issues.</li><li>Testing of materials/components to meet attainment and release metrics.</li></ul><p></p><p><b>Manage Information</b></p><ul><li>Assisting in updating and issuing documentation, including SOP’s, as required.</li><li>Accurately documenting laboratory work and instruct any less experienced analysts on the best documentation practices.</li><li>Complete peer review of documented lab results, logbooks, and associated documents to ensure testing has been completed in compliance with procedures.</li></ul><p></p><p><b>Safety</b></p><ul><li>Prioritise safety in every aspect of the role.</li><li>Lead by example in exemplifying safety behaviours</li></ul><p></p><p><b>Teamwork</b></p><ul><li>Participate in cross functional teams.</li><li>Provide support to other departments to ensure qualification and production schedules are adhered to.</li><li>Development</li><li>Coach analysts within the group.</li><li>Training of laboratory personnel and scheduling of training where required.</li></ul><p></p><p><b>Housekeeping</b></p><ul><li>Maintain lab to highest standards to ensure all assigned areas are maintained by designees.</li><li>Perform all other activities as indicated by Supervisor.</li></ul><p></p><p><b>Designee Responsibilities </b></p><p>Can act as a designee for the Manager, QC Materials Management, for the following task:</p><ul><li>May sign documentation on behalf of other Material Management Analyst. May have other Material Management Analyst, Technical Leads, Managers and Supervisors sign documentation on behalf of the Raw Material Analyst.</li><li>May be assigned by Supervisors, Managers, and other Senior Analysts to sign documents on their behalf.</li><li>Complete work scheduling a