Job Description

Senior Specialist LIMS in Albuquerque, NM

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.

Essential job duties:

LIMS Administration and System Ownership
1. Serve as site administrator and Quality Control business owner for the LabVantage LIMS platform.
2. Manage system configuration, master data, test methods, specifications, sampling plans, stability protocols, instrument mappings and workflow definitions.
3. Administer LIMS user accounts, roles, permissions and periodic access reviews in accordance with company procedures and data integrity requirements.
4. Monitor system performance and coordinate resolution of system issues with IT and vendors.
5. Act as primary site liaison for vendor support, upgrades, system enhancements and troubleshooting activities.

Validation and Compliance
1. Coordinate and lead validation activities associated with LIMS implementation, upgrades, enhancements and maintenance.
2. Develop and maintain user requirements, risk assessments, test protocols, traceability matrices, validation reports and supporting documentation.
3. Ensure compliance with current Good Manufacturing Practices (cGMP, FDA 21 CFR Part 11, data integrity expectations, and company procedures.
4. Support periodic reviews and system lifecycle management activities.

Change Control and Continuous Improvement
1. Serve as Quality Control representative and business owner for LIMS-related change controls.
2. Assess proposed system changes for regulatory, business, validation and operational impact.
3. Collaborate with stakeholders to identify, prioritize and implement system improvements.
4. Support deployment of new functionality, integrations and automation initiatives.

User Support and Training
1. Provide technical support and guidance for laboratory personnel utilizing LIMS.
2. Develop and maintain training materials, work instructions and operating procedures.
3. Deliver user training related to new system functionality and process changes.
4. Investigate and resolve system-related issues impacting laboratory operations.

Master Data Governance
1. Establish and maintain standards for LIMS master data creation, review, approval and maintenance.
2. Ensure data accuracy, version control, traceability and compliance with data governance requirements.
3. Support implementation of new products, methods, specifications and laboratory workflows within the system.
4. Maintain data mapping and associated technical documentation.

Cross-Functional Collaboration
1. Partner with QC, QA, Manufacturing, Stability, Regulatory Affairs and Information Technology teams to understand business requirements and optimize laboratory workflows.
2. Coordinate testing activities associated with new functionality, upgrades and integrations
3. Participate in project teams supporting digital laboratory initiatives.

Audit and Inspection Support
1. Support internal audits, customer audits and regulatory inspections involving laboratory computerized systems.
2. Provide system documentation, records, validation packages and subject matter expertise during inspections.
3. 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 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 workflows.
Preferred
• Experience with LabVantage LIMS
• Experience leading LIMS implementations, upgrades or migration projects.
• Experience supporting laboratory instruments and system integrations
• Experience with electronic laboratory systems such as ELN, LES, CDS, or stability management systems.
• Experience with SQL, reporting tools, or LIMS configuration tools.

Knowledge, Skills and Abilities
• 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.

Other Qualifications:
• 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

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.