Specialist, Shop Floor Quality Assurance Cell Therapy, Overnight (6p - 6a)
Company: Bristol Myers Squibb
Posted on: August 5, 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.
Bristol-Myers Squibb is seeking a Shop Floor (Field) QA Specialist
for the QA Operations organization at the Cell Therapy Facility in
Devens, MA. As our Field QA Specialist, you will be responsible for
quality activities for the Cell Therapy Facility in accordance with
Bristol-Myers Squibb policies, standards, procedures, and Global
cGMP. Functional responsibilities include ensuring manufacturing
compliance with applicable procedures and batch records, providing
real time review of manufacturing batch record documentation and
logbooks, and working with operations to resolve manufacturing
issues. The Field QA Specialist role is stationed in Devens, MA and
reports to the Head of QA Field for the Devens CTF.
This role has the hours of 6 p.m. - 6 a.m. with rotational
* Perform QA shop floor activities.
* Ensure manufacturing compliance with applicable procedures and
* Perform real time review of manufacturing batch records.
* Review manufacturing shop floor documentation.
* Must have strong authorship and ability to critically review
investigations, interpret results and generate technical
conclusions consistent with Quality risk management principles.
* Must be skilled in planning and organizing, decision-making, and
* Knowledge of quality processes, change control, product
complaints, deviations, investigations, and CAPA management.
Qualifications and Education Requirements:
* High School Degree required.
* Relevant college or university degree preferred.
* Minimum 2 years relevant work experience, with experience in a
Quality Assurance role.
* Equivalent combination of education and experience
* Must be action-oriented and skilled in decision-making, building
relationships, problem solving, conflict management, planning and
organizing, resource allocation, coaching others, and analytical
* Understands continuous improvement and improves efficiency and
productivity within the group or project.
* Builds relationships internally within and with cross functional
* Must have sound knowledge and experience in FDA regulated cGMP
warehousing, Quality, and compliance environments. Prefer to also
have knowledge of GMP Manufacturing operations and processes.
* Directs quality initiatives that accomplish continuous
improvement and enhance site quality system efficiencies.
* Routinely recognizes and resolves Quality issues; Informs
management of proposed solutions. Seeks management guidance on
* Able to recognize conflict and notify management with proposed
recommendations for resolution.
* Must possess an independent mindset. Work is self-directed.
* Requires moderate direction to complete more complex tasks;
completes routine tasks with little or no supervision.
* Confident in making decisions for non-routine issues.
* Develops and revises procedures.
* Intermediate to advanced ability to interpret results and
situations and articulate recommendations for resolution.
* Able to prepare written communications and communicate problems
to management with clarity and accuracy.
* Able to effectively multi-task.
* Knowledge of US and global cGMP requirements.
* Able to lift up-to 25 pounds several times a day.
* Able to stand and walk for several hours at a time in a 12-hour
* Able to move between rooms in a timely manner.
* Able to work near strong magnetic fields.
* Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety
shoes, safety glasses, gloves, coveralls, booties, etc.).
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 ...@bms.com
(mailto:...@bms.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
Keywords: Bristol Myers Squibb, Nashua , Specialist, Shop Floor Quality Assurance Cell Therapy, Overnight (6p - 6a), Healthcare , Ayer, New Hampshire
Didn't find what you're looking for? Search again!