Senior Specialist, Quality Assurance Lot Disposition
Company: Bristol-Myers Squibb
Location: Bothell
Posted on: April 15, 2024
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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 .
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.
Our Quality Assurance and Compliance organization is pivotal in
upholding quality standards within aseptic manufacturing, with core
competencies in Microbiology and Chemistry. Our oversight extends
across the entire product lifecycle, encompassing manufacturing,
batch release, investigations, customer feedback management,
document control, Quality Control testing, and diligent audits. Our
team harnesses cutting-edge analytical and biologic test methods,
leveraging state-of-the-art instrumentation and streamlined digital
processes to meticulously affirm control.
The Senior Specialist of Quality Assurance (QA) Lot Disposition is
a full-time position located at the BMS Cell Therapy Manufacturing
Plant (Jump) in Bothell, WA. The primary focus for this role is to
ensure final drug products and incoming raw materials are released
to market following all internal procedures and cGMP requirements.
This position reports directly to the Senior Manager of Quality
Assurance - Lot Disposition.
Shift Available:
Responsibilities:
Conduct routine lot disposition activities for finished drug
products and incoming raw materials by ensuring all relevant
documentation associated with a lot are accounted for, completed,
and approved under cGMP standards.
Review and approve the QC documentation related to each lot
(Certificate of Analysis and QC testing data, including EM and
analytical data).
Perform the review of lot genealogy for all raw materials and
components used in each drug product lot to ensure they are
approved and released using the electronic system (MES -
Manufacturing Execution System or ERP - Enterprise Resource
Planning System).
Conduct the drug product lot disposition process and ensure the
dosage assignment is reviewed and approved by the appropriate
individuals.
Collaborate with stakeholders and management and communicate lot
disposition status; monitor progress and issue status reports.
Assemble and review Quality system documents such as, deviations,
batch production records, test methods, specifications, and
controlled forms associated with each lot for disposition.
Create and revise relevant Standard Operating Procedures (SOP),
Work Instructions (WI), Forms, and Reference Documents as
needed.
Support internal and external audit activities, batch record
reviews, change controls, and other QA department needs as
identified by management. Champion and foster a positive and
successful quality culture, aligned with BMS' existing culture.
Support continuous improvement projects to improve efficiency of
the manufacturing and related business processes.
Work is performed in a typical office environment, with standard
office equipment available and used. Work is generally performed
seated but may require standing and walking for up to 10% of the
time. Lighting and temperature are adequate and there are no
abnormal conditions caused by noise, dust, etc.
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.
Knowledge & Skills:
Knowledge of cGMP regulations and FDA guidance's applicable to
biologics and cell therapy.
Detail oriented with strong good documentation practices
expertise.
Direct experience with lot disposition supporting the
manufacturing, testing, disposition, and distribution of cGMP
products.
Demonstrated excellence in written and verbal communication.
Demonstrated ability to work cross-functionally and to develop and
maintain strong business partner relationships.
Basic Requirements:
Bachelor's degree in life or physical science discipline or an
equivalent combination of education and work experience.
4 years of cGMP experience required.
2 years of Quality experience required (either QA, QC or a
combination).
Preferred Requirements:
Lot disposition experience.
QMS experience.
Technical writing skills.
The starting compensation for this job is a range from $75,000 to
$95,000, 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: R1579775
Updated: 2024-04-13 03:35:00.494 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.
Keywords: Bristol-Myers Squibb, Kirkland , Senior Specialist, Quality Assurance Lot Disposition, Other , Bothell, Washington
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