CSV QA Analyst
Company: Insight Global
Location: Rahway
Posted on: April 25, 2024
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Job Description:
Our Biopharmaceutical client is seeking a CSV QA Analyst to join
their team in Rahway, NJ. This individual will lead Quality
Assurance oversight for computer system validation matters within
the Global Development Quality Organization. They will act at the
quality unit representative for the clinical supply group for IT
products such as infrastructure, business applications, shop floor
automation systems and standalone, laboratory instrument systems.
They will promote and build Quality Management System elements into
the end-to-end computer system validation process, thereby
promoting permanent inspection readiness. This individual will
consult, assess and assist with risk based, tailored approaches for
computer system validation activities and testing. They will
provide independent Quality Assurance oversight for the
implementation of new computerized systems, change control involved
with existing computerized systems as well as the retirement of
computerized systems in the Clinical Supply domain. They will
develop and maintain an overall computer system validation posture
and program for a defined functional area(s) (single point of
contact) within Clinical Supply, including support for System
Development Life Cycle deliverables and testing and act as a
liaison with respect to the Quality Management System and
Compliance pillars of Global Development Quality for the purposes
of investigations, corrective action/preventive action, procedural
controls, auditing and Quality Risk Management.
We are a company committed to creating diverse and inclusive
environments where people can bring their full, authentic selves to
work every day. We are an equal opportunity/affirmative action
employer that believes everyone matters. Qualified candidates will
receive consideration for employment regardless of their race,
color, ethnicity, religion, sex (including pregnancy), sexual
orientation, gender identity and expression, marital status,
national origin, ancestry, genetic factors, age, disability,
protected veteran status, military or uniformed service member
status, or any other status or characteristic protected by
applicable laws, regulations, and ordinances. If you need
assistance and/or a reasonable accommodation due to a disability
during the application or recruiting process, please send a request
to HR@insightglobal.com .
To learn more about how we collect, keep, and process your private
information, please review Insight Global's Workforce Privacy
Policy: https://insightglobal.com/workforce-privacy-policy/ .
Required Skills & Experience
- B.S. and/or M.S. degree in an appropriate Life Science, Computer
Science, Information Technology or Engineering discipline
- 5+ years of experience in pharmaceutical/biotechnology
industry
- experience in a regulated environment
- 5+ years of CSV, SLC, and QA functions
- High level of expertise and exposure with agency regulations,
such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US
Food and Drug Administration.
- High level of expertise in SLC methodology (e.g., V-model,
waterfall, agile, spiral) including change management.
Nice to Have Skills & Experience
- Experience with calibration and qualification
- Expertise with configuration management
- Some level of experience with IT Infrastructure Language and
service management
Benefit packages for this role will start on the 31st day of
employment and include medical, dental, and vision insurance, as
well as HSA, FSA, and DCFSA account options, and 401k retirement
account access with employer matching. Employees in this role are
also entitled to paid sick leave and/or other paid time off as
provided by applicable law.
Keywords: Insight Global, Jersey City , CSV QA Analyst, Professions , Rahway, New Jersey
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