Specialist, Quality Assurance Operations OTF, Cell Therapy
Company: Disability Solutions
Location: Bothell
Posted on: May 3, 2024
Job Description:
Working with UsChallenging. 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. "
- W ill 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 .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 CareersWith 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/
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.
Keywords: Disability Solutions, Shoreline , Specialist, Quality Assurance Operations OTF, Cell Therapy, Healthcare , Bothell, Washington
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