Working with UsChallenging. 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.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 .Bristol Myers Squibb IrelandBristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business unitsLocated 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 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.For more information about Bristol Myers Squibb, visit us at The RoleBMS Cruiserath Biologics is seeking to recruit aPermanentSenior Specialist, QC Quality Systems (Lead Investigator), reporting to the QC Quality Systems Team Lead. The QC Quality Systems Specialist will be part of a team who are responsible for supporting the Quality Control team with Investigations and Change ControlsKey Duties And ResponsibilitiesLead and manage QC Investigations assignedFacilitate root cause analysis and problem solving sessionsComplete the generation of associated investigation reportsDetermine and create CAPA's, Effectiveness Reviews, and Supplemental Tasks as requiredPresent investigations at IRB to senior managementLeading and coordinating the initiation, implementation, and closure of QC Change ControlsEnsuring the timely completion of all activities related to these quality systemsCollation of metrics/KPI's and generation of associated dashboard read-outCommunication with BMS local and global stakeholdersLead huddles, meetings, conference calls and provide read-outsParticipate in the OpEx strategy and support process improvementsParticipate in internal and external auditsSupport additional QC analytical services activities, as requiredQualifications, Knowledge and Skills RequiredProficiency in communication and collaboration at a variety of levelsProven success working well in a team environment with flexibility to react to changing business needsDemonstrated problem solving, project management abilityExcellent time management and organizational skillsExcellent technical writing skilsPrevious investigations experience is an assetAbility to research and have an excellent understanding of new areas/tasks/assays under investigation promptlyEducation minimum of a B.Sc. Biochemistry or related disciplineAt least 3 years' experience, in a GMP laboratory setting ideally within a biologics laboratoryA minimum of 1 years' experience with demonstrated effectiveness using quality systems (investigations/change controls - Trackwise/Infinity) in a FDA and EMA regulated environmentKnowledge of biologics QC testing (Separations, Bioanalytical, Microbiology or Raw Materials) is desirableWhy you should applyYou will help patients in their fight against serious diseasesYou will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employeesYou'll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical assurance, 27 day annual leave, life assurance and on-site gymIf you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your roleSite-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to. Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.