GxP Laboratory Informatics & CSV Specialist

Pharmaron Beijing Co. Ltd.; Coventry (RI); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

401(k) Retirement Plan

Paid time off & holidays

Employee assistance program

Job summary

Pharmaron Beijing Co. Ltd. in Coventry, RI seeks a Computer System Validation/QC Informatics Specialist to manage laboratory data platforms and workflows within QC & Analytical. The role collaborates with IT and QA to minimize downtime and ensure compliance across CSV activities.

The candidate should have a strong background in GxP, LIMS systems, and data integrity, with demonstrated ability to train users and support audits in a regulated environment.

Qualifications

• MSc or BSc in Chemistry or Computer Science with GxP experience.
• Direct experience with laboratory information management systems (LIMS).
• Understanding of QMS, 21 CFR Part 11 and data integrity.

Responsibilities

• Lead qualification activities as part of CSV lifecycle (IQ, OQ, PQ).
• Manage GxP software upgrades and system configurations in QC/Analytical.
• Provide end-user training and liaise with IT and QA for compliance.
• Support audits and maintain data integrity across systems.

Skills

GxP compliance

Liaison across IT & QA

Cross-functional work

Documentation & reporting

Analytical thinking

Education

MSc or BSc in Chemistry

MSc or BSc in Computer Science

Tools

LIMS

NuGenesis LMS

SDMS

ELN

Job description

Pharmaron Beijing Co. Ltd. in Coventry, RI seeks a Computer System Validation/QC Informatics Specialist to manage laboratory data platforms and workflows within QC & Analytical. The role collaborates with IT and QA to minimize downtime and ensure compliance across CSV activities.

The candidate should have a strong background in GxP, LIMS systems, and data integrity, with demonstrated ability to train users and support audits in a regulated environment.