Senior Specialist, Quality Assurance Lot Disposition

About the Role

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.

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.

Responsibilities

• Conduct routine lot disposition activities for finished drug products and incoming raw materials by ensuring all relevant documentation associated with a lot are accounted for, completed, and approved under cGMP standards.
• Generate, review, and approve the Certificate of Analysis against release specifications. Ensure EM data are approved and any excursions are documented within a QMS record.
• Collaborate with stakeholders and management and communicate lot disposition status, monitor progress, and issue status reports.
• Perform the review of lot genealogy for all raw materials and components used in each drug product lot to ensure they are approved and released using the electronic system (MES - Manufacturing Execution System or ERP – Enterprise Resource Planning System).
• Perform the drug product lot disposition process and generate, review, and approve Release For Infusion (RFI) documentation.
• Assemble and review Quality system documents such as deviations, batch production records, test methods, specifications, and controlled forms associated with each lot for disposition.
• Create and revise relevant Standard Operating Procedures (SOP), Work Instructions (WI), Forms, and Reference Documents as needed.
• Support internal and external audit activities, CAPAs, change controls, and other QA department needs as identified by management.
• Champion and foster a positive and successful quality culture, aligned with BMS’s existing culture.
• Support continuous improvement projects to improve efficiency of the manufacturing and related business processes.
• Represent the Quality unit at various project meetings and provide quality input in the resolution of quality-related issues.
• Act as subject matter expert for QA oversight of cGMP operations during audits and regulatory inspections.

Work is performed in a typical office environment, with standard office equipment available. Work is generally performed seated but may require standing and walking for up to 10% of the time.

Requirements

• 3-5 years working in a Quality role within a commercial or clinical biopharmaceutical, cellular therapy, or gene therapy organization.
• Bachelor’s degree in life or physical science discipline or an equivalent combination of education and work experience.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy.
• Detail-oriented with strong documentation practices expertise.
• Direct experience with lot disposition supporting the manufacturing, testing, disposition, and distribution of cGMP products.
• Demonstrated excellence in written and verbal communication.
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.

Schedule

Tuesday - Saturday schedule with flexible starting time to be determined based on team and operational needs.

Pay

Bothell - WA - US: $92,290 - $111,837 (full-time employee 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.

Benefits

• 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:
  • US Exempt Employees: Flexible time off (unlimited, with manager approval) and 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio).
  • Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year’s Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.