Senior Specialist, Quality Control Compliance, Cell Therapy (R1557878-en-us)
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 of through the electronic quality management system at the Jump location in Bothell, WA. The Sr. Specialist on the QC Compliance team is responsible for operating within Quality Control and cross-functionally, driving improvements, collecting data and information, and working collaboratively with stakeholders in Quality, Manufacturing, or other functional areas, and project teams while ensuring compliance to company quality requirements.
- Responsible for Quality Control change control and change records at Jump.
- Oversee or perform impact assessments and change actions to ensure completion in a timely and efficient manner.
- Provide consistent support to QC to ensure records are managed through document and/or quality management systems.
- Complete assigned change controls, deviations, CAPAs, change controls and laboratory investigations in a timely and efficient manner.
- Responsible to support laboratory investigations for non-conforming (OOS) results and deviation investigations and CAPA at Jump.
- Own and lead Change Controls, CAPA and Deviation, or Laboratory Investigations.
- Collaborate cross-functionally and within QC to support implementation of new processes, equipment, or continuous improvement projects that promote effective and efficient operations and comply with cGMP requirements.
- Develop a solid understanding of the Quality Control release testing processes, environmental monitoring process and the associated risk management controls.
- Collaborate with other stakeholders across the organization and assist in the continuous improvement of Change Control, Investigations, CAPA and management within QC.
- Champion and foster a positive and successful collaborative quality culture, aligned with existing culture.
- Act as subject matter expert for QC GMP change controls, or associated activities during regulatory inspections.
- Other responsibilities as assigned.
Qualifications and Education Requirements
- Bachelor's Degree and 8+ 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 and 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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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