LIMS Master Data Governance Business Analyst / Admin
Location: Mount Pocono
Posted on: June 23, 2025
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Job Description:
LIMS Master Data Governance Business Analyst / Admin Fully
onsite – Swiftwater, PA Must have experience - 1 years of
experience in use and administration of a LabWare LIMS specifically
creation of product specs, sample plans and item codes. - Strong
working knowledge of laboratory processes including cGMP’s in a
pharmaceutical environment. - Experience in system testing,
validation, and master data management (LIMS) - Familiar with 21CFR
part 11 data integrity best practices in pharmaceutical environment
(previous FDA experience)- must have - Excellent written and verbal
communications skills and the ability to lead and participate in
teams - Experience or familiarity of the Laboratory Environment
(highlighted lab exp) - Provide technical support of LIMS to
Quality Control, Batch Release, Production, Stability and R&D
operations (responding to tickets, helping users) Preferred/ Nice
Have Skills: -Additional LIMS experience, building master data
Position Summary: The Lab Information Management System [LIMS]
Business Administrator is essential to Quality Operations at the
Swiftwater site for supporting the maintenance and improvement of
the LIMS system. Maintenance support will include supporting
Business Administrators in, updating master data for new and
existing products, updating master data for new and existing
analysis, maintaining system documentation, and providing ad hoc
support to other departments. The position is expected to provide
leadership to support system evolution and continuous improvement,
and to support laboratory informatics needs. This role will support
the creation and updating of master data to support the site
transition to to a new ERP. Translation of data from existing
documents to the electronic system for use in production and QC.
Position Responsibilities: - Ensure site on-time implementation of
new iSHIFT system (ERP) activities through support of master data
configuration and data migration and SOP revisions. - Provide
technical support of LIMS to Quality Control, Batch Release,
Production, Stability and R&D operations - Provide first level
diagnostic of incidents and support business users, IS LIMS
Administrator and Support Center in the management and timely
resolution of technical - Responsible for the master data
management process including the updating of specifications and
supporting the approval process - Manage Global System update and
changes which may include new modules and workflow changes -
Configure and Maintain instrument interfaces to Laboratory
equipment - Ensure that the LIMS complies with all relevant
regulatory standards - Support the business in the creation and
updating of training materials as changes to system occur - Ensure
that the LIMS complies with all relevant regulatory standards
Technical competencies and soft skills: Working knowledge of
aseptic processes, biology, chemistry, life sciences Knowledge of
cGMPs and regulatory requirements with Strong analytical & balanced
decision-making skills Good GMP documentation For immediate
response, please send resume to agautam@valiantiq.com
Keywords: , East Brunswick , LIMS Master Data Governance Business Analyst / Admin, IT / Software / Systems , Mount Pocono, New Jersey
