Scientist, QC Compliance Micro, 1st Wed- Sat
Company: Bristol-Myers Squibb
Posted on: June 25, 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 in
Summit, NJ is searching for a remarkable Senior Scientist, QC
Compliance Microbiology to join our growing team! The Senior
Scientist QC Compliance Microbiology will work both independently
and with the team overseeing all of the QC microbiology related
compliance records across Deviations, CAPA's and Change Control. As
our Sr. Scientist, you will be primarily responsible for providing
technical assessments in relation to product impact, disposition
assessments, root cause analysis, and hypothesis driven
investigational testing plans. In addition, you will work closely
with the Lab Excellence team on areas for improvements. This
position is part of the Summit Quality Control Compliance Team,
which is comprised of two pillars: Compliance and Continuous
Improvement. While this is a site-based role, collaboration across
other sites in the CTDO network and the BMS Global network is
essential.*This role works Wednesday - Saturday, Day Shift*Role
- Identify opportunities for operational improvement in the
Quality Control department for Deviations, Corrective and
Preventative Actions and Change Control relative to CTDO and Summit
- S12 goals.
- Responds to challenges and additional workload in a
professional and objective manner.
- Ability to multitask, prioritize workload, document properly
and interpret data accurately.
- Collaborate with other Site and network Operational Excellence
team members to ensure initiatives external to the S12 site can be
leveraged to obtain intended benefit of those external
- Excellent writing and presenting skills.
- Develop and implement standard operating procedures, work
practices and guidance.
- Carry out responsibilities in accordance with the organizations
policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures
(cGMP), USP, EU and other global regulatory requirements at all
- Follow directions properly, work cooperatively as an individual
contributor and as a team member.
- Communicate effectively with QC peers, cross-functional peers
- Author and revise controlled documents such as Standard
Operating Procedures and Controlled Forms. Author non-routine
Protocols/Validation Plans/ reports as needed.
- Support investigations and CAPAs associated with QC
- Support data trending and tracking of results and draw
conclusions from said data.
- Take ownerships/accountability of assigned tasks and come up
with solutions/improvement suggestions.Role Requirements:
- Bachelors degree in Microbiology, Molecular Biology, or related
discipline. An equivalent combination of education and experience
will be considered.
- Minimum 3 years of experience working in a regulated
- Must have strong microbiological technical skills to provide
assessments in relation to product impact, disposition assessments,
root cause analysis, and hypothesis driven investigational testing
- Must have strong authorship and be able to critically review
investigations, interpret results and generate technical
conclusions consistent with Quality risk management
- Must be able to routinely recognize quality issues and
interpret problems, as well as propose solutions for complex
- Must understand continuous improvement and be able improve the
compliance and efficiency of the quality system.
- Must be able to effectively prepare and convey data analysis to
management and others within the group with clarity and
- Must be self-directed, complete routine tasks independently and
be confident in making decisions in respective subject matter area,
consulting with management for decisions outside of established
- Comfortable providing input/guidance to others within the
department and across the organization in deviations technical
- Knowledge of problem-solving methods used to perform Root Cause
- Propose solutions for issues and work with management to
- Able to prepare written communications and communicate problems
to management with clarity and accuracy.
- Able to support internal and health authority inspections of
- Equipment Usage During Work Period: Computer 70%; Phone and
Electronic Devices 30%.
- Sitting at a computer terminal for an extended period.
- Requirement to work in a conference room / meeting environment
for moderate periods of time.
- Occasional periods in labs or production area, requiring some
level of gowning.
- Light to moderate lifting.
- Regular, predictable attendance is required, plus flexibility
with schedule (weekends, holidays, extended hours) as business
- Moderate noise i.e., business office with computers, phone, and
printers.BMSCART, VETERANAround 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 .
Visitto 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
Keywords: Bristol-Myers Squibb, New York , Scientist, QC Compliance Micro, 1st Wed- Sat, Other , Summit, New York
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