Bristol Myers Squibb
Senior Specialist, Quality Assurance Lot Disposition
Bristol Myers Squibb, Bothell, Washington, United States, 98021
Senior Specialist, Quality Assurance Lot Disposition
Position at 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.
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 or ERP).
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.
This job description describes the general nature and level of work performed and does not restrict other duties as required by management.
Work Schedule
Work Shift 4 x 10hrs / Day. Weekend and holiday work is required (Sat-Mon and Wed 8am - 6pm).
Qualifications
3-5 years working in a Quality role within a commercial or clinical biopharmaceutical, cellular therapy, or gene therapy organization.
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.
Compensation 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.
Benefits and Other Information 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/.
BMS is committed to equal employment opportunity and provides accommodations in the recruitment process in accordance with applicable law. If you require reasonable accommodations/adjustments in completing this application, please contact adastaffingsupport@bms.com.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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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 or ERP).
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.
This job description describes the general nature and level of work performed and does not restrict other duties as required by management.
Work Schedule
Work Shift 4 x 10hrs / Day. Weekend and holiday work is required (Sat-Mon and Wed 8am - 6pm).
Qualifications
3-5 years working in a Quality role within a commercial or clinical biopharmaceutical, cellular therapy, or gene therapy organization.
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.
Compensation 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.
Benefits and Other Information 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/.
BMS is committed to equal employment opportunity and provides accommodations in the recruitment process in accordance with applicable law. If you require reasonable accommodations/adjustments in completing this application, please contact adastaffingsupport@bms.com.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
#J-18808-Ljbffr