Associate Specialist , Quality Assurance, Cell Therapy
Company: Bristol Myers Squibb
Posted on: May 14, 2022
At Bristol Myers Squibb, we are inspired by a single vision -
transforming patients' lives through science. In oncology,
hematology, immunology and cardiovascular disease - and one of the
most diverse and promising pipelines in the industry - each of our
passionate colleagues contribute to innovations that drive
meaningful change. We bring a human touch to every treatment we
pioneer. Join us and make a difference.PURPOSE AND SCOPE OF
POSITION:The Quality Associate 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
perspective within a regulated cGMP environment.The primary focus
of the QA Associate 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.
REQUIRED COMPETENCIES: Knowledge, Skills, and
- 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.Experience
- 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
disposition is preferred.
DUTIES AND RESPONSIBILITIES: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
- Provide Quality support to Manufacturing personnel on the
floor; provide guidance during GMP events and initiation of
- Review deviations, product non-conformities, and GMP
investigations to ensure adequate.
- Own department events and minor deviations
- 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 ausits, including documenting
observations and implementation of corresponding CAPAs.
- Lead small scope projects as assigned
- Revise Standard operating Procedures as needed.
- Train and mentor junior team members
Knowledge, Skills, and Abilities
- Strong computer skills with Word and Excel and other electronic
- Detail oriented team player with effective planning,
organization and execution skills.
- Must exercise accurate judgment and be able to evaluate
information critically and decide upon appropriate course of
- Good organization and time management skills.
- Ability to work in a high paced team environment.
- Strong written and verbal skills.
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
- May work in areas with exposure to vapor phase liquid nitrogen
and other chemicals.
- Must be able to gown per requirements to enter manufacturing
- 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.Around the
world, we are passionate about making an impact on the lives of
patients with serious diseases. Empowered to apply our individual
talents and diverse perspectives in an inclusive culture, our
shared values of passion, innovation, urgency, accountability,
inclusion and integrity bring out the highest potential of each of
our colleagues.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.Physical presence at the BMS
worksite or physical presence in the field is an essential job
function of this role which the Company deems critical to
collaboration, innovation, productivity, employee well-being and
engagement, and 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.Our company
is committed to ensuring that people with disabilities can excel
through a transparent recruitment process, reasonable workplace
adjustments and ongoing support in their roles. Applicants can
request an approval of accommodation prior to accepting a job
offer. If you require reasonable accommodation in completing this
application or if you are applying to a role based in the U.S. or
Puerto Rico and you believe that you are unable to receive a
COVID-19 vaccine due to a medical condition or sincerely held
religious belief, during or any part of the recruitment process,
please direct your inquiries to email@example.com. Visit
careers.bms.com/eeo-accessibility to access our complete Equal
Employment Opportunity statement.Any data processed in connection
with role applications will be treated in accordance with
applicable data privacy policies and regulations.
Keywords: Bristol Myers Squibb, Seattle , Associate Specialist , Quality Assurance, Cell Therapy, Healthcare , Bothell, Washington
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