SENIOR SPECIALIST, DATA INTEGRITY
Company: Bristol-Myers Squibb
Location: Summit
Posted on: October 19, 2024
Job Description:
Senior Specialist, Data IntegrityWorking with Us
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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.The Senior Specialist, Data Integrity
role is responsible for assisting with the implementation and
management of Bristol Myers Squibb's GMP Data Governance and Data
Integrity program at the Summit West, NJ CAR T manufacturing
facility. This includes implementing documentation and processes in
support of the laboratories, manufacturing, and GMP support
areas.Shift Available:
Mon-Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.Responsibilities:
- Responsible for executing data integrity documentation periodic
reviews and performing risk monitoring of implemented systems
across all sites to ensure continued compliance.
- Responsible for assisting with the implementation of Global
Data Integrity Processes at the site and ensuring that Global
programs are implemented on-time.
- Assist in ensuring local site activities are harmonized with
Global DG/DI standards.
- Provide feedback and support to GMP areas in scope during
process improvement, while ensuring compliance with Global DG/DI
policies and standards.
- Responsible for ensuring systems at Summit West, NJ CAR T
facilities comply with data life cycle requirements from initial
data creation/recording to archival and decommissioning.
- Responsible for creating and executing data integrity
assessments of new and existing systems including, but not limited
to, manufacturing and laboratory systems to ensure compliance with
regulatory requirements and company established requirements for
data integrity.
- Drive mitigation and remediation when data integrity gaps are
identified.
- Work with functional area SMEs at Summit West CAR T facility to
ensure data risks are identified, remediated and prevented.
- Seek out and recommend to management opportunities for
increased data integrity program efficiencies and operational
improvement.
- Provide the GMP functions any updates regarding data integrity
regulations that they may be impacted by.Knowledge & Skills:
- Must have familiarity with GMPs, Quality, and Data Integrity
principles.
- Must be familiar with system validation principles.
- Must be familiar with the ALCOA+ principles and their
application to both electronic and paper data.
- Must be able to effectively interpret problems and communicate
in an impactful manner to management and the group.
- Must provide guidance to other employees in the interpretation
and correction of data integrity issues.
- Must be able to critically review and author technical
reports.
- Completes routine tasks with little to no supervision;
Confident in making decisions in their subject matter area.
- Drives continuous improvement projects and improve efficiency
and productivity within the group or project.
- Support and lead cross functional project teams driving
performance and results.
- Strong project management skills with the ability to
effectively communicate.
- Recognizes data integrity risks and ensures remediation efforts
are driven to completion.Basic Requirements:
- Relevant college or university degree preferred. Equivalent
combination of education and experience acceptable.
- Minimum 3-5 years relevant work experience with data
integrity.
- Minimum 1-2 years equipment and system validation
experience.
- Experience with PC based office computers and standard
Microsoft Office applications.Preferred Requirements:
- Preferred experience with Risk Management Principles and
projects.
- Preferred experience with electronic document and data
management systems.Working Conditions:
- 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.
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Keywords: Bristol-Myers Squibb, Middletown , SENIOR SPECIALIST, DATA INTEGRITY, Other , Summit, Connecticut
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