Senior Specialist, Quality Assurance Laboratory Operations

Working with Us 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. 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: careers.bms.com/working-with-us Position Summary Bristol Myers Squibb is seeking Senior Specialist, Quality Assurance Laboratory Operations for the Quality Assurance (QA) organization at the Cell Therapy Facility (CTF) in Devens, MA. The Senior Specialist, Quality Assurance Laboratory Operations is responsible for quality activities for the Cell Therapy Facility Quality Control (QC) Laboratory in accordance with Bristol-Myers Squibb policies, standards, procedures and Global cGMPs. Functional responsibilities include ensuring compliance with applicable procedures and analytical methods, providing real time review of laboratory documentation and logbooks, and working with QC to resolve issues and investigations, assess changes, and prepare for regulatory inspections. This role is stationed in Devens, MA and reports to the Senior Manager, QA Laboratory Operations, Cell Therapy. Key Responsibilities •Provides QA oversight of QC laboratory operations including exception reporting, investigations and corrective or preventative actions and associated projects •Provides QA oversight of QC activities related to environmental and critical utility monitoring •Performs QA assessment of QC-driven change controls and supports related actions, including changes associated with the Laboratory Information Management System (LIMS). •Supports laboratory operations/continuous improvement and risk management projects and participates in risk assessments related to QC laboratory operations •Identifies and reports discrepancies from required work practices or procedures to management •Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate •Participates as requested in the response team for audits and inspections by health authorities •Conducts regular walkthroughs of Quality Control laboratories •Supports Network functions as QA review and approval on qualification/ technical protocols and reports, as applicable •Reviews and approves Quality, Laboratory, and Analytical SOPs and documents, and develops and revises department SOPs, as needed Qualifications & Experience •High School Degree required •Relevant college or university degree preferred. •Minimum 5 years relevant work experience, with at least three years in a Quality Assurance role. •Equivalent combination of education and experience acceptable. •Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. •Understands continuous improvement and improves efficiency and productivity within the group or project. •Builds relationships internally within and with cross functional teams. •Must have sound knowledge and experience in FDA regulated cGMP environments. Prefer to also have knowledge of QC analytical and microbiology laboratory operations and processes. •Able to recognize conflict and notify management with proposed recommendations for resolution. •Must possess an independent mindset. Work is self-directed. •Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. •Confident in making decisions for non-routine issues. •Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. •Able to prepare written communications and communicate problems to management with clarity and accuracy. •Able to effectively multi-task. If 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 Careers With 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 an inclusive culture, promoting diversity 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 Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. COVID-19 Information To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.