Senior Specialist, Quality Assurance

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 Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, and management of implementation of required changes to meet cGMP and internal standards.

This role supports Jump’s activities for routine clinical and commercial product release at JuMP with an emphasis on supporting Quality Control (QC) with a Quality perspective within a regulated cGMP environment.

The primary focus of the QA Specialist role will be to support routine clinical and commercial activities related to QC to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture at JuMP by providing Quality oversight to QC and environmental monitoring programs as well as ensuring documentation is complete, accurate and in accordance with approved and effective standard operating procedures and specifications.

QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities):

Education: Bachelor’s degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required. 

Experience:

• 5-8 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals, cell therapy manufacturing, or quality control is preferred.

• Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.

• Knowledge and experience in Quality Assurance processes, cGMP regulations and FDA, EU, ICH guidance applicable to biologics and cell therapy manufacturing/quality control.

• Knowledge of Quality Control regulatory compliance systems related to in-process, intermediate, final release and stability testing of drug product.

• Strong written and verbal skills.

• Strong computer skills with Word and Excel and other electronic manufacturing systems.

• Detail oriented team player with effective planning, organization, time management and execution skills.

• Strong individual contributor with demonstrated ability to work independent in a fast-paced environment.

• Excellent communication, trouble-shooting, and problem-solving skills

ROLES AND RESPONSIBILITIES:

• Provide oversight of cleanroom environmental programs including environmental monitoring (EM), cleaning and sanitization, and facility controls.

• Own, Revise, Review, and Approve complex documentation in support of GMP operations at JuMP, including but not limited to facility plans, validation and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.

• Proactively identify and resolve technical and compliance issues/gaps and support cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.

• Provide support and acts as QA Subject Matter Expert to multiple areas within and potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge.

• Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.).

• Collaborate with stakeholders within and outside of the JuMP Manufacturing Facility, and communicate equipment, facility and system status; monitor progress and issue status reports.

• Conduct Quality on the Floor activities including quality walk-throughs of the testing and warehouse locations.

• Provide Quality support to Quality Control personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.

• Support internal and external audits, including documenting observations and oversee implementation of corresponding CAPAs.

• Lead and participate in small to large scope projects as assigned as QA Subject Matter Expert (SME)

WORKING CONDITIONS (US Only):

• While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. 

• May work in areas with exposure to vapor phase liquid nitrogen and other chemicals. 

• Must be able to gown per requirements to enter laboratory space. 

• Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection. 

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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