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Job Details


Bristol Myers Squibb

Manager, Quality Assurance

Technology

Quality Assurance

Yearly

No

Bothell, Washington, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Purpose:

The Quality Assurance Lot Disposition team is responsible for overseeing and supporting Product Disposition operations at the Juno Manufacturing Plant (JuMP) located in Bothell, WA. The Manager, Quality Assurance - Lot Disposition is responsible for conducting the disposition of finished drug products.

Education:

  • Bachelor’s degree in a life or physical science discipline.

Experience:

  • Minimum of 7 years working in a Quality role within a commercial or clinical biopharmaceutical, cellular therapy, or gene therapy organization.

Knowledge, Skills, and Abilities

  • Knowledge of cGMP regulations and FDA guidance’s 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.
  • Excellent communication, trouble shooting, and problem-solving skills.
  • Strong team player that can also work independently to achieve objectives.

Key Responsibilities

  • Conduct routine lot disposition activities for finished drug products by ensuring all relevant documentation associated with a lot are accounted for, completed and approved under cGMP standards.
  • Review and approve the QC documentation related to each lot (Certificate of Analysis and QC testing data, including EM and analytical data).
  • Perform the review of lot genealogy for all raw materials and components used in each lot to ensure they are approved and released using the electronic system (Manufacturing Execution System).
  • Conduct the lot disposition process and ensure the Dosage assignment is reviewed and approved by the appropriate individuals.
  • Collaborate with stakeholders and management and communicate lot disposition status; monitor progress and issue status reports.
  • 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, batch record reviews, change controls, and other QA department needs as identified by management.

Working Conditions:

  • Regular sitting, standing, talking, listening, using hands & fingers to operate a computer and telephone keyboard reach
  • Requirement to work in an office environment, potentially requiring ergonomic considerations
  • Requirement to work in a conference room / meeting environment for moderate periods of time
  • Occasional periods in labs or production area, requiring some level of gowning
  • Occasional domestic or international travel
  • Light to moderate lifting
  • Regular, predictable attendance is required, plus occasional overtime, as business demands dictate

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.