QC LIMS Developer

Fujifilm•Research Triangle Park, NC

6d•Onsite

About The Position

The QC LIMS Developer designs, configures, validates, and supports Laboratory Information Management System (LIMS) capabilities for Quality Control laboratories. This role builds compliant digital workflows for sample lifecycle, stability, specifications, CoAs, instrument/data integrations, and reporting, ensuring data integrity, GMP compliance, and on-time product/material release.

Requirements

Bachelor’s in Computer Science/Information Systems, Chemistry, Biochemistry, or related field.
3–7 years configuring and supporting LIMS in GMP environments (pharma/biotech/med device).
Hands-on with one or more platforms (e.g., LabWare, LabVantage, SampleManager, Nautilus, STARLIMS).
Proven CSV experience and familiarity with FDA 21 CFR 210/211/11, EU Annex 11, GAMP 5, ICH Q9/Q10.
Understanding of QC lab processes (raw materials, compendial testing, stability, EM/utilities, microbiology, chromatography workflows).
Scripting/config: SQL; LabWare LIMS Basic or LabVantage Java/Groovy; .NET/Java/Python for integrations; XML/JSON.
Databases: Oracle and/or SQL Server.
Interfaces: file-based integrations; experience with CDS (Empower/Chromeleon), ELN/LES, and label systems.
Reporting: Crystal Reports, Jasper, Power BI/Tableau; LIMS native query/report tools.
Strong requirements gathering, documentation, and communication.
Analytical problem solving; ability to translate lab needs into scalable, compliant solutions.
Stakeholder management and training aptitude; comfortable in fast-paced, regulated settings.
Strong analytical and problem-solving skills.

Nice To Haves

Master’s a plus.
Knowledge of LabWare LIMS version 8 table relationships.
Experience with Crystal reports.
Excellent verbal and written communication skills.

Responsibilities

Designs, configures, validates, and supports LIMS capabilities for Quality Control laboratories.
Builds compliant digital workflows for sample lifecycle, stability, specifications, CoAs, instrument/data integrations, and reporting.
Ensures data integrity, GMP compliance, and on-time product/material release.
Translates QC business requirements into LIMS workflows (sample login, testing, results entry/review/approval, CoA generation, stability, EM, utilities, raw materials, in-process/finished product).
Configures master data: tests, methods, specifications, limits, calculations, units, instruments, users/roles, security, audit trails, electronic signatures.
Builds dashboards, queries, and reports (KPIs, turnaround time, RFT metrics, EM trending, stability pulls) using native LIMS tools and reporting platforms.
Integrates instruments and systems (CDS such as Empower; ELN; ERP like SAP/Oracle).
Implements results parsing and automated calculations; manages instrument metadata and result mapping.
Authors and executes CSV deliverables: URS, FRS, HDS, configuration specs, risk assessments, test scripts (IQ/OQ/PQ), validation summary reports.
Ensures 21 CFR Part 11 / EU Annex 11 adherence, ALCOA+ data integrity, and Good Documentation Practices; maintains change control and periodic review.
Supports audits/inspections; maintains audit-readiness for LIMS and connected systems.
Provides application support, incident/problem management, and root-cause analysis; monitors job/integration health and performance.
Manages environments and releases (dev/test/qual/prod), versioning, and migrations; follows SDLC and Agile/Scrum practices.
Leads data migration/cleanup projects; builds scripts for bulk loads and master data maintenance.
Creates user guides/SOPs/WIs; trains end users (multiple departments).
Identifies digital opportunities to reduce cycle time and errors; implements templates, macros, and standardized builds across sites/products.
Partners with QC, QA, Validation/CSV, IT Security, and Manufacturing to align solutions with contamination control strategy and right-first-time goals.