Senior Specialist LIMS

Curia • Albuquerque, NM

4d • Onsite

About The Position

The LIMS Senior Specialist serves as the Quality Control business owner and site administrator for the LabVantage 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.

Requirements

• Bachelor’s degree in Chemistry, Biology, Life Sciences, Engineering, Computer Science or related field.
• Minimum 5 years of experience in a GMP-regulated pharmaceutical, biotechnology or life sciences environment.
• Minimum of 2 years of experience supporting LIMS administration, configuration, implementation or system ownership.
• Experience with computerized laboratory systems and business processes.
• Knowledge of cGMP regulations, FDA 21 CFR Part 11 requirements, data integrity principles, and computer system validation requirements.
• Understanding of laboratory testing processes and analytical method validation and transfer.
• Strong understanding of laboratory operations and regulated computerized systems.
• Strong knowledge of data integrity and computerized system validation principles.
• Ability to independently manage system configuration and maser data activities.
• Strong project management and organizational skills.
• Excellent troubleshooting and root cause analysis capabilities.
• Strong written and verbal communication skills.
• Ability to work effectively across Quality, IT and laboratory organizations.
• Ability to manage multiple priorities in a fast-paced GMP environment.
• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.
• May be required to obtain and maintain gowning certification.
• May be required to obtain and maintain media qualification.
• May be required to wear a respirator.

Nice To Haves

• Experience with LabVantage LIMS
• Experience leading LIMS implementations, upgrades or migration projects.
• Experience supporting laboratory instruments and system integrations, preferably in small molecule environments.
• Experience with electronic laboratory systems such as ELN, LES, CDS, or stability management systems.
• Experience with SQL, reporting tools, or LIMS configuration tools.

Responsibilities

• Serve as site administrator and Quality Control business owner for the LabVantage 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior