Associate II, Quality Control, Cell Therapy

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, CAPA, change controls and supporting cGMP record management through the electronic quality management system at the Jump location in Bothell, WA. The QC Associate II on the QC Compliance team is responsible for supporting laboratory operations with investigations to determine root cause and corrective actions, change controls and data management. This position will be responsible for operating within Quality Control and cross-functionally at Jump, collecting necessary data and information associated with QC investigations, corrective actions, and change controls, and support efficient, compliant, and timely record processing and data analysis.

Job Responsibilities

• Responsible for Quality Control laboratory and related investigation corrective action that prevent the deviation from recurring for non-conforming (OOS) results and deviation investigations at Jump.
• Responsible for supporting Quality Control related change controls (CC) to address corrective action, a project, or another objective.
• Complete assigned CAPAs and CC activities in a timely, compliant, and efficient manner.
• Provide consistent support to QC to ensure timely completion of investigations, CAPA and CCs to ensure on-going record management with the quality system.
• Develop an understanding of the Quality Control testing processes, environmental monitoring process and the associated controls.
• Collaborate with stakeholders and management and communicate investigation, CAPA, CC status as appropriate.
• Collaborate with other stakeholders across the organization and assist in the continuous improvement of investigation, CAPA and CC processes and management within QC.
• Actively involved with tracking and analyzing data for QC related investigation, CAPA and CC records, and partnering with stakeholders to identify improvement opportunities.
• Champion and foster a positive and successful collaborative quality culture, aligned with the existing culture within Jump and at BMS.
• Participate on CAPA or CC teams, projects and other initiatives.

Qualifications and Education Requirements

• Bachelor's Degree and 2+ years of relevant cGMP experience, or equivalent combination of education and experience.
• Experience in regulated industry Quality Control function or 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.

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