Senior Specialist, Quality Assurance Training
Company: Bristol Myers Squibb
Location: Bothell
Posted on: January 25, 2023
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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
PURPOSE AND SCOPE OF POSITION (Position Summary):
The Quality Assurance Training Senior Specialist position plays a
key role in supporting the cGMP quality operations for the Bothell
Manufacturing Plant (Jump). - Primary Responsibilities include
oversight of training and timely qualification of Quality
Associates on all processes, procedures, and practices necessary to
support product manufacturing and product disposition, as well as
meet cGMP and internal standards.
In addition to onboarding coordination and training of new hires,
the QA Training Senior Specialist will also be responsible for
training curriculum management in accordance with training policies
and procedures, change control/CAPA action ownership related to
training, review and revision of cGMP Controlled Documents related
to training, and supporting routine clinical and commercial
activities related to QA to ensure consistent compliance with
regulatory and industry expectations.
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.
QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities):
Education:
Bachelor's degree in relevant science or engineering discipline is
preferred. Minimum of an Associates degree and/or equivalent
combination of education and experience is required.
Experience:
5-8 years of relevant cGMP experience. Experience in FDA/EMA
regulations in biopharmaceuticals, cell therapy manufacturing, or
quality control is preferred.
Experience working with Subject Matter Experts and translating
content and performance requirements into sound training
content.
Knowledge of adult learning methods, strategies, and
techniques.
Excellent written, verbal, and presentation skills.
Strong communication, analytical, and problem-solving skills.
Demonstrated ability to interface, coach, and influence.
Knowledge of learning management systems and web delivery tools
Ability to receive and provide feedback in a constructive way.
Must possess the ability to take initiative to complete assignments
and job responsibilities with minimal supervision.
Experience with use of complex research techniques and
methodologies like six sigma and Kaizen to improve process/product
quality is a plus.
Knowledge of cGMP regulations and FDA, EU, ICH guidance applicable
to biologics and cell therapy manufacturing/quality control.
Strong computer skills with Word and Excel and other electronic
manufacturing systems.
Detail oriented team player with effective time management,
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.
Ability to work in a fast-paced team environment.
Ability to manage multiple priorities simultaneously, have a strong
drive orientated on results.
License/Certifications:
N/A
ROLES AND RESPONSIBILITIES:
Maintain, evolve, and improve the training lifecycle program for QA
Ops O n-The-Floor TF Team to ensure compliance with approved
procedures.
Support and lead the training and on-boarding of all QA associates
for the QA Ops On-The-Floor Team for all tasks including but not
limited to facilitating system access, navigation of systems, batch
record review, product receipt, product packaging, gowning,
deviations, and document review.
Support and own necessary change control and CAPA actions related
to revision of training procedures and curriculums.
Own, Revise, and Approve Standard operating Procedures and training
documents as needed.
Conduct Quality on the Floor activities including quality
walk-throughs of the manufacturing, QC areas, and warehouse
locations.
Act as QA Subject Matter Expert (SME) and support cross functional
groups on root cause analysis and development of corresponding
corrective and preventive actions.
Lead small to large scope projects as assigned.
Participate in small and large cross functional project groups as
QA Subject Matter Expert (SME), related to training.
Support internal and external audits, including documenting
observations and oversee implementation of corresponding CAPAs.
May provide support to QA Ops OTF department when available and
participate in tasks including but not limited to batch record
review, product receipt, product packaging, deviations, and
document reviews.
May Own, Review, and approve deviations, product non-conformities,
and GMP investigations to ensure adequate resolution and compliance
with current Good Manufacturing Practices (GMPs).
TRAVEL REQUIREMENTS:
--' Not Applicable
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.
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.
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.
The starting compensation for this job is a range from $75,000 -
$95,000 , 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.
BMSCART, Veteran, #LI-Onsite
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 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.
Keywords: Bristol Myers Squibb, Seattle , Senior Specialist, Quality Assurance Training, Other , Bothell, Washington
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