Position SummaryThe Senior Specialist of Quality Assurance Lot Disposition (QALD) is a full-time position at the Bristol Myers Squibb (BMS) Bothell, WA Cell Therapy manufacturing site. The primary focus for this role is to ensure final drug products and incoming raw materials are released to market following all internal procedures and cGMP requirements. This position reports directly to the Senior Manager of Quality Assurance - Lot Disposition.
Duties/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, 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 and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
- This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Work Shift: Tuesday - Saturday schedule with flexible starting time to be determined based on team and operational needs.
Qualifications- 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 good 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.
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Compensation Overview:Bothell - WA - US: $92,290 - $111,837
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 Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- 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
Based on eligibility*, 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 Years 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.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
