Senior Specialist I, QC LIMS Configuration Specialist

7 hours ago


Mount Holly Springs, Pennsylvania, United States FUJIFILM Corporation Full time
About This Role

The QC LIMS Sr. Specialist 1 is accountable for supporting the Laboratory Information Management system (LIMS) in accordance with regulatory, corporate, and scientific guidelines. This role is responsible for configuration, validation, and ongoing maintenance within the LIMS platform.

This position is accountable to support documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state of control. The QC LIMS Sr. Specialist 1 works closely with Quality Control, Analytical Development, Manufacturing, and Quality Assurance to ensure compliance with GMP requirements.

Key Responsibilities
  • Participates in the rollout of Labware Laboratory Information Management System (LIMS) v.8 go live for the site.
  • Collaborates with business subject matter experts to define and document new or revised LabWare requirements.
  • Configures basic and advanced LabWare LIMS objects, including specifications, analyses, batch templates, test lists, QC samples, calculations, and various templates.
  • Executes qualification or verification testing to support final implementation of LabWare configuration additions/revisions.
  • Maintains and repairs configuration objects within Labware LIMS.
  • Supports in creating queries to support business requirements.
  • Works within the change management system to update configurations for specifications, analyses, and other static data within LIMS, as needed.
  • Provides timely response and user support, including troubleshooting applications, creating new configuration templates, and maintaining change records in accordance with version control procedures.
  • Provides LIMS training, technical support, problem reporting, and resolution to Quality Control laboratory, QA, AD, and Manufacturing staff, as needed.
  • Evaluates data generated and/or stored within the System to provide ad hoc and long-term reporting solutions that address business needs and identify process gaps that might otherwise go unnoticed.
  • Writes test scripts for new LIMS functionality and participates in the validation of new functionality.
  • Develops and maintains process configurations in System based on end-user procedures and requirements.
  • Collaborates with the LIMS team, IT department, and LIMS users to ensure new functionality meets user requirements.
  • Creates and revises supporting documentation for LIMS, including SOPs, work instructions, design specifications, training materials.
  • Supports the expansion of the LIMS platform through the preparation and execution of test scripts for system validation.
  • Liaises with end-users in the Laboratory to ensure changes to configurations meet the needs of the end user.
  • Revises or develops LIMS functional requirement specifications and user requirement specifications, as well as other relevant documentation.
  • Performs other related duties as assigned.
Requirements
  • B.S. degree in Computer Sciences, Information Technology, Biology, Microbiology, Biochemistry, or other relevant scientific discipline.
  • 3+ years' experience working in a cGMP Quality Control department or in a FDA-regulated industry (drugs/biologics).
  • Previous experience with Labware LIMS development or other LIMS software development.
  • Leadership aptitude is beneficial.
  • cGMP/ ICH/ FDA regulations with 21 CFR Part 11 and GAMP experience, preferred.
  • Trackwise System experience for at least 1 year or similar.


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