Sr. Specialist, Quality Assurance Drug Product Disposition Cell Therapy

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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. 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 . The Sr. Specialist, Quality Assurance Drug Product Disposition, Devens Cell Therapy role is responsible for supporting quality and disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. This role will aid in the routine and timely release of drug product and assure the quality of manufactured products is in compliance with all applicable regulations and guidelines. This individual will support the Sunday-Wednesday shift and be responsible for working 4 days a week with 10 hour day shifts. Functional responsibilities include preparing deliverables for product release within the inventory management system (SAP) or Cell Health Intelligence Platform (CHIP), ensuring accurate and timely maintenance and review of batch record documentation and authoring or reviewing departmental SOP's and Work Practices. Develops and maintains Standard Operating Procedures, training, and business processes supporting drug product disposition. Prepares documentation and deliverables per Standard Operating Procedures required for drug product disposition. Verifies accuracy and acceptability of drug product documentation, such as Certificate of Analysis or deviation reports, to support drug product lot disposition. Performs the review of batch genealogy for all raw materials and components used in each batch to ensure that they are approved and released. May perform required updates to lot status in applicable quality systems Works in electronic systems such as SAP, Learning Management, and Document Management systems. Coordinates with internal and external stakeholders to troubleshoot issues when required. Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations. Provides guidance to less experienced staff with atypical events during day-to-day operations. May own Quality System records such as deviations, CAPAs, or Change Controls. Performs Release for Infusion to calculate patient dosage. Specific Knowledge, Skills, Abilities: Minimum of 4 years of directly relevant experience in a regulated cGMP environment. Previous quality experience is preferred. Education/Experience/ Licenses/Certifications: B. S., in science, engineering, biochemistry, related discipline, or its equivalent. Any combination of education, experience, and military service in line with recommendations above will be considered. 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. Compensation Overview: Devens - MA - US: $89,780 - $108,789 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employee

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