Specialist, Quality Assurance, Cell Therapy

Company: Bristol Myers Squibb
Location: Bothell
Posted on: January 27, 2023

Job Description:

Working with Us
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

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.

This position is for Sunday - Wednesday 6am-4:30pm

Education/Experience
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.
3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
Hands-on experience with batch record review and product disposition.

Knowledge, Skills, and Abilities
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Strong computer skills with Word and Excel and other electronic manufacturing systems.
Detail oriented team player with effective planning, organization 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.
Must be able to correlate events and determine the action plan required to avoid incidents recurrence and apply them.
Extensive experience in Quality Assurance processes.
Good organization and time management skills.
Ability to work in a high paced team environment.
Strong written and verbal skills.

Key Responsibilities
Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations.
Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
Review deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).
Act as QA Subject Matter Expert (SME), and support cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.
Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
Oversee manufacturing operations during patient material receipt and drug product pack out.
Support the review and approval of incoming raw materials, routine preventive and calibration of equipment.
Support internal and external audits, including documenting observations and oversee implementation of corresponding CAPAs.
Revise Standard operating Procedures as needed.
Train and mentor junior associates.

The starting compensation for this job is a range from $65,000 - $82,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decid ed based on demonstrated experience. For more on benefits, please visit our BMS Careers site . Eligibility for specific benefits listed in our careers site may vary based on the job and location.

#LI-onsite Veteran BMSCART

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.
Work in areas that may have strong magnets.
May work in areas with exposure to vapor phase liquid nitrogen
Must be able to obtain gowning qualification to enter a cleanroom environment
May be required to work nights, weekends and holidays in a 10-hour shift structure.
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.---

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
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.

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

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.

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