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Bristol Myers Squibb Specialist, Quality Control Compliance, Cell Therapy in Bothell, Washington

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 and Scope of Position:

The Quality Control Compliance and System Support team is responsible for laboratory and related investigations and CAPA and supporting cGMP record management of through the electronic quality management system at the Jump location in Bothell, WA. The QC Specialist on the QC Compliance team is responsible for initiating or investigating Laboratory Investigations and deviations to determine root cause and corrective actions. This position will be responsible for operating within Quality Control and cross-functionally within Jump, collecting necessary data and information associated with QC and laboratory investigations and determine the associated corrective action to prevent the deviation from reoccurring.

Job Responsibilities

  • Responsible for Quality Control laboratory investigations for non-conforming (OOS) results and deviation investigations at Jump.

  • Complete assigned laboratory investigations, deviations and CAPAs in a timely and efficient manner.

  • Provide consistent support to QC to ensure timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone during regulatory inspections.

  • Develop a solid understanding of the Quality Control release testing processes, environmental monitoring process and the associated risk management controls.

  • Collaborate with stakeholders and management and communicate investigation status to as appropriate.

  • Collaborate with other stakeholders across the organization and assist in the continuous improvement of investigations, CAPA and management within QC.

  • Champion and foster a positive and successful collaborative quality culture, aligned with Juno’s existing culture.

  • Act as subject matter expert for QC GMP deviation or investigations during regulatory inspections.

Qualifications and Education Requirements

  • Bachelor's Degree and 4+ of relevant cGMP experience, or equivalent combination of education and experience.

  • Experience in Quality Control function in a cGMP manufacturing operation.

  • Experience in FDA/EMA or similar regulation in biotechnology or cellular therapy field is preferred.

  • Demonstrated proficiency excellence in written and verbal communication.

Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.

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.

Company: Bristol Myers Squibb

Req Number: R1557667

Updated: 2022-05-18 02:37:57.422 UTC

Location: Bothell,Washington

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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