Senior Specialist LIMS

Senior Specialist LIMS

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer:

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

The LIMS Senior Specialist serves as the Quality Control business owner and site administrator for the Lab Vantage Laboratory Information Management System (LIMS). This position is responsible for configuration, master data governance, user administration, system lifecycle management, validation support, and continuous improvement of the LIMS platform. The role partners closely with Quality Assurance, Information Technology, laboratory personnel, and external vendors to ensure the system remains compliant, reliable, and aligned with business and regulatory requirements.

Essential job duties:

• LIMS Administration and System Ownership
• Serve as site administrator and Quality Control business owner for the Lab Vantage LIMS platform.
• Manage system configuration, master data, test methods, specifications, sampling plans, stability protocols, instrument mappings and workflow definitions.
• Administer LIMS user accounts, roles, permissions and periodic access reviews in accordance with company procedures and data integrity requirements.
• Monitor system performance and coordinate resolution of system issues with IT and vendors.
• Act as primary site liaison for vendor support, upgrades, system enhancements and troubleshooting activities.
• Validation and Compliance
• Coordinate and lead validation activities associated with LIMS implementation, upgrades, enhancements and maintenance.
• Develop and maintain user requirements, risk assessments, test protocols, traceability matrices, validation reports and supporting documentation.
• Ensure compliance with current Good Manufacturing Practices (cGMP, FDA 21 CFR Part 11, data integrity expectations, and company procedures.
• Support periodic reviews and system lifecycle management activities.
• Change Control and Continuous Improvement
• Serve as Quality Control representative and business owner for LIMS-related change controls.
• Assess proposed system changes for regulatory, business, validation and operational impact.
• Collaborate with stakeholders to identify, prioritize and implement system improvements.
• Support deployment of new functionality, integrations and automation initiatives.
• User Support and Training
• Provide technical support and guidance for laboratory personnel utilizing LIMS.
• Develop and maintain training materials, work instructions and operating procedures.
• Deliver user training related to new system functionality and process changes.
• Investigate and resolve system-related issues impacting laboratory operations.
• Master Data Governance
• Establish and maintain standards for LIMS master data creation, review, approval and maintenance.
• Ensure data accuracy, version control, traceability and compliance with data governance requirements.
• Support implementation of new products, methods, specifications and laboratory workflows within the system.
• Maintain data mapping and associated technical documentation.
• Cross-Functional Collaboration
• Partner with QC, QA, Manufacturing, Stability, Regulatory Affairs and Information Technology teams to understand business requirements and optimize laboratory workflows.
• Coordinate testing activities associated with new functionality, upgrades and integrations.
• Participate in project teams supporting digital laboratory initiatives.
• Audit and Inspection Support
• Support internal audits, customer audits and regulatory inspections involving laboratory computerized systems.
• Provide system documentation, records, validation packages and subject matter expertise during inspections.
• Support investigations and corrective actions related to LIMS, data integrity and laboratory systems.

Education, Experience, Certification and Licensures

Required:

• Bachelor's degree in Chemistry, Biology, Life Sciences, Engineering, Computer Science or related field.
• Minimum 5 years of experience in a GMP-regulated…