What are the responsibilities and job description for the Laboratory Information Management System (LIMS) Senior Specialist (contingent) position at STA Pharmaceutical?
Overview
We are seeking a LIMS Senior Specialist to join our GMP-regulated laboratory environment. The ideal candidate will manage day-to-day LIMS operations, lead and execute GMP validation and computerized system validation (CSV) activities, support system configuration and integration, and perform hands-on development where required. Strong French and English communication skills and adherence to regulated quality standards are essential.
Qualifications
- CFC or Bachelor's degree in Life Sciences, Computer Science, Information Systems or related field.
- Experience in GMP validation and CSV for laboratory computerized systems (IQ/OQ/PQ, validation protocols, traceability).
- Practical programming/scripting skills (e.g., Labware scripting, SQL, .NET, Python, or similar) for customization, report development and data integration.
- Understanding of laboratory workflows, sample lifecycle and data integrity principles.
- Familiar with integration technologies and protocols (e.g., REST/API, HL7, OPC, FTP, database interfacing).
- Excellent verbal and written French and English communication skills; able to produce
Responsibilities
- Administer and maintain the Labware LIMS platform to ensure reliable, secure, and compliant operation in a GMP environment.
- Plan, execute and document GMP validation/CSV activities for LIMS changes, upgrades and integrations.
- Develop, review and maintain SOPs, work instructions and validation documentation related to LIMS operation and change control.
- Provide day-to-day operational support: access roles, troubleshooting, incident management and routine maintenance.
- Lead or support system integration projects (e.g., instruments, WMS, ELN, SAP) including requirements gathering, design, testing and deployment.
- Perform LIMS configuration, scripting and customization within Labware framework; develop and maintain custom modules, reports, queries and interfaces when necessary.
- Implement and support data integrity controls and best practices aligned with ALCOA principles.
- Train and support end users and prepare training materials.
- Participate in change control, CAPA and audit responses; support internal and external regulatory inspections.
- Liaise with IT, QA, laboratory management and vendors to ensure effective cross-functional collaboration.