Senior Specialist, QA Laboratory Operations

<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></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></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></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></p><p>For more information about Bristol Myers Squibb, visit us at BMS.com/ie</p><p></p><p></p><p>The Role</p><p></p><p>BMS Cruiserath Biologics is seeking to recruit on a permanent Senior Specialist, QA Laboratory Operations, reporting to the Senior Manager, QA Laboratory Operations. The Senior Specialist will provide expert QA support for Quality Control Operations at BMS Cruiserath Biologics.</p><p></p><p>The role will support the Global Biologics Laboratory, performing commercial finished product testing and release activities, and QC Site Operations for the manufacture of Biologic Drug Substance. In addition, the Senior Specialist will also provide quality oversight for Contract Test laboratories, Method Transfer activities and Equipment Qualification activities.</p><p></p><p>Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.</p><p></p><p></p><p>Key Duties and Responsibilities:</p><ul><li>QA review and approval activities for:<ul><li>Laboratory investigations and deviations and associated corrective actions.</li><li>Contract testing laboratories investigations and associated documentation</li><li>Operational SOPs, test methods, forms and directives</li><li>Annual product reviews</li><li>Trending reports</li><li>Laboratory equipment/instrument qualification protocols and reports</li><li>Protocols and reports for method validations and technical transfers</li><li>Change controls</li></ul></li><li>Establishing best practices and continuous improvement initiatives to ensure compliance of all QC activities to all applicable policies, directives, guidance documents and regulatory requirements.</li><li>Supporting the QC laboratories through global regulatory agency inspections and achievement of market approvals.</li><li>Supporting the execution of the self inspection programme</li><li>Supporting QC and QA Network Harmonisation initiatives. </li></ul><p></p><p></p><p>Qualifications, Knowledge and Skills Required:</p><ul><li>Minimum of a BSc in Science or related discipline</li><li>Minimum of 3 years Quality experience in the biopharmaceutical industry</li><li>A thorough understanding of cGMP requirements for laboratory compliance including equipment, instrumentation and method qualification requirements</li><li>Excellent written and verbal communication skills</li><li>Ability to work on his/her own initiative in addition to working as part of a team</li><li>Ability to work across a team matrix in order to meet accelerated timelines</li><li>Excellent time management &amp; organisational skills along with a proven ability to multi-task.</li></ul><p></p><p></p><p>Why you should apply:</p><ul><li>You will help patients in their fight against serious diseases.</li><li>You will be part