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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us .

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Quality Assurance 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, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards. This role directly supports Jump’s release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at Jump with an emphasis on supporting Manufacturing with a Quality on-the-floor presence within a regulated cGMP environment.  

The primary focus of the QA Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture at Jump by ensuring documentation is complete, accurate and that batch records are executed in accordance with approved and effective standard operating procedures and specifications. 

The QA Specialist primary role is on-the-floor and contributes with off-the-floor projects and activities that are just as significant as on-the-floor work.

Shift Available:

• Sunday - Wednesday, 9 p.m. - 7:30 a.m.

Responsibilities:

• Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.  

• Provide Quality on-the-floor oversight including quality walk-throughs of the production, testing and warehouse locations to ensure practices fully adhere to cGMP.

• Provides technical knowledge and guidance towards GMP compliance during triage/troubleshooting activities. 

• Review deviations, product non-conformities, and GMP investigations to ensure compliant resolution and adherence to current Good Manufacturing Practices (cGMPs). 

• Own, review, and approve deviations, including Deviation classification and completion of Impact Assessments, as applicable.

• Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.  

• Oversee manufacturing operations from patient material receipt to drug product pack out.  

• May support internal and external audits, including documenting observations.

• Own and participate in review and approval for CAPAs.

• Identify and facilitate continuous improvement projects.

• Revise Standard operating Procedures as needed, and review/approve document revisions.

• Drives right first time (RFT) by providing direct training, guidance, and problem solving to peers.

• Provide training, coaching, and feedback for GMP guidance.

• Continue support of continuous improvement culture and operational excellence methodologies.

• Support change control initiatives as applicable.

Knowledge & Skills:

• Working knowledge and/or ownership of the following quality systems:Change Control, CAPAs, Deviations, Management Monitoring and Self Inspection auditing, QA reporting, and approval of GMP documentation.

• 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.  

• Proven experience working on teams where combined contribution, collaboration, and results were expected.   

• Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.  

• Ability to work in a high paced team environment.  

• Strong written and verbal skills.  

Basic Requirements:

• High school diploma is required.  

• 3 years of experience in a cGMP environment within a Quality or Manufacturing role.

Preferred Requirements:

• Bachelor’s degree in relevant science or engineering discipline is preferred.

• Hands-on experience with batch record review and product disposition is preferred.  

Working Conditions:

• 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 that may have strong magnets.

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

• Must be able to gown per requirements to enter manufacturing 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. 

The starting compensation for this job is a range from $65,000 to $82,000, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site (https://careers.bms.com/working-with-us) .

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical,

pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).

Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like

tuition reimbursement and a recognition program.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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: R1580507

Updated: 2024-05-15 02:20:10.239 UTC

Location: Bothell-WA

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.