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LIMS Support Specialist

2 weeks ago

Toronto, Ontario, Canada PharmEng Technology Full time


LIMS Support Specialist Quality Control (QC)

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 Canada & US.