About the job LIMS Support Specialist
LIMS Support Specialist Quality Control (QC)
Onsite | Swiftwater, PA
Consulting or Full-Time Opportunity
We are seeking a LIMS Support Specialist to provide hands-on support to the Quality Control (QC) department. This role involves LIMS configuration, master data governance, and project support activities aligned with GMP and regulatory requirements.
Key Responsibilities
LIMS Configuration & Technical Support
-
Customize and configure the LIMS platform to align with lab workflows, testing needs, and terminology.
-
Modify standard software code or develop new code to meet unique lab requirements.
-
Ensure user workflows, reports, and data elements are integrated without altering base code.
-
Serve as the LIMS System Owner, managing system changes and upgrades.
Data Governance & Compliance
-
Build and support a master data governance model for vaccine product specifications and analytical testing.
-
Ensure alignment with cGMP and data integrity requirements across QC instruments and systems.
-
Manage and maintain master specification documents for commercial products.
-
Oversee static master data for QC-LIMS, ensuring data accuracy, ownership, and semantic consistency.
-
Support audit readiness, regulatory inspections, and compliance-driven documentation.
Cross-Functional Collaboration
-
Work closely with internal QC teams, IT development teams, and global stakeholders.
-
Support the Data Logistics & Support (DLS) Department in meeting operational and project milestones.
-
Lead and contribute to LIMS master data management efforts for analytical testing portfolios.
Qualifications
-
Experience supporting or configuring LIMS platforms (LabWare, STARLIMS, or similar) in a GMP-regulated environment.
-
Familiarity with QC laboratory workflows, analytical testing, and regulatory compliance.
-
Strong understanding of master data governance and scientific data semantics.
-
Proficient in LIMS system ownership, change control processes, and cross-department coordination.
-
Excellent documentation, communication, and stakeholder engagement skills.
Note: Applicants must be eligible to work in the U.S.