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Specialist, Quality Control Compliance at Bristol Myers Squibb

Specialist, Quality Control Compliance

Bristol Myers Squibb Bothell, WA Full-Time

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

Job Responsibilities

  • Responsible for Quality Control (QC) related change control and change records at Jump.
  • Responsible for Quality Control laboratory investigations for non-conforming (OOS/OOA/OOT) results and deviation investigations at Jump.
  • Complete assigned change controls, laboratory investigations, and CAPAs in a timely and efficient manner.
  • Provide consistent support to QC to ensure timely completion of investigations, CAPA and change controls to ensure on-going consistency and record management with the quality system.
  • Develop a solid understanding of the Quality Control release testing processes, environmental monitoring process and the associated risk management controls.
  • Actively involved with tracking and analyzing data for QC related investigation, CAPA and CC records, and partnering with stakeholders to identify improvement opportunities.
  • Collaborate with other stakeholders across the organization and assist in the continuous improvement of investigations, CAPA, change control and management within QC.
  • Collaborate with stakeholders and management and communicate investigation, CC or CAPA status to as appropriate.
  • Maintains and routinely communicates an up-to-date dashboard of department-specific CAPA to show current status and escalate issues to help drive on-time phase completion, including deviation closure by the original due date.
  • Participate on laboratory investigation, CAPA or change control teams, projects, and other initiatives.
  • Champion and foster a positive and successful collaborative quality culture, aligned with Bothell sites existing culture.
  • Act as subject matter expert for QC GMP deviation or laboratory 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.

THINK BIG. BE BRAVE. DELIVER.

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 [ Email address blocked ] - Click here to apply to Specialist, Quality Control Compliance. 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.

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