Specialist, Quality Assurance, Cell Therapy
Company: Bristol Myers Squibb
Posted on: January 27, 2023
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:
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
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
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
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
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.
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
Provide Quality support to Manufacturing personnel on the floor;
provide guidance during GMP events and initiation of deviation
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
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
May be required to work nights, weekends and holidays in a 10-hour
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 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
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
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.
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 email@example.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
Any data processed in connection with role applications will be
treated in accordance with applicable data privacy policies and
Keywords: Bristol Myers Squibb, Seattle , Specialist, Quality Assurance, Cell Therapy, Healthcare , Bothell, Washington
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