GxP CSV & Lab Informatics Specialist

Pharmaron; Coventry (RI); Sur place; USD 80 000 - 120 000; Plein temps

Avantages offerts par ce poste

Medical, dental & vision insurance

401(k) with employer match

Paid time off and holidays

Life insurance

Résumé du poste

Pharmaron in Coventry, RI is seeking a Computer System Validation/QC Informatics Specialist to support the Quality Control & Analytical department with laboratory data platforms and workflows.

You will lead GxP qualification activities (IQ/OQ/PQ), coordinate with IT and QA to ensure compliance, provide end-user training, and support audits while maintaining data integrity across laboratory systems.

Qualifications

• MSc or BSc in Chemistry, or Computer Science, or related fields with minimum of 5 years of GxP experience.
• If qualified in chemistry or a related field, then strong IT supporting experience must be demonstrated including data structures, programming, or information systems.
• If qualified in computer science or related field, strong experience in analytical lab support with chemistry terminology and workflows is required.
• Direct experience with laboratory informatics (LIMS) systems.
• Understanding of QMS, ALCOA+, 21 CFR Part 11, and Data Integrity principles.
• Ability to work cross-functionally between IT and scientific teams.
• Knowledge of FDA, EMA, GAMP, ICH guidance related to data integrity.
• Experience managing stepwise implementation and qualification projects.
• Knowledge of pharmaceutical compliance and industry requirements.
• Experience administering NuGenesis LMS, SDMS, and ELN.

Responsabilités

• Lead lab improvement efforts related to laboratory information handling such as custom reports, ELN, LIMS configuration, and data workflows.
• Coordinate with IT to manage GxP software upgrades, installations, and rollouts for business continuity.
• Perform GxP qualification activities (IQ/OQ/PQ) and prepare related documentation.
• Demonstrate expertise with NuGenesis LMS, SDMS, ELN, and other lab systems.
• Provide end-user training for system owners and users.
• Communicate business priorities between end users and IT.
• Build strong relationships with stakeholders and support audits as needed.

Connaissances

GxP compliance

Cross-functional collaboration

Documentation

Communication

Formation

MSc or BSc in Chemistry or Computer Science

Outils

LIMS

NuGenesis LMS

SDMS

ELN

Description du poste

Pharmaron in Coventry, RI is seeking a Computer System Validation/QC Informatics Specialist to support the Quality Control & Analytical department with laboratory data platforms and workflows.

You will lead GxP qualification activities (IQ/OQ/PQ), coordinate with IT and QA to ensure compliance, provide end-user training, and support audits while maintaining data integrity across laboratory systems.