CSV Specialist - Laboratory at QRC Group, Inc

Manatí, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Jan, 26

Salary

0.0

Posted On

18 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Computer Systems Validation, Laboratory Systems, GMP, Data Integrity, System Lifecycle Management, CMMS Systems, Calibration Documentation, Electronic Data Archival, Change Controls, Technical Documentation, Preventive Maintenance, User Access Evaluations, SOPs, Audit Trail Reviews, EHS Compliance, Technical Drawings

Industry

Staffing and Recruiting

Description

Company Description QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions! Job Description The CSV Specialist - Laboratory to lead and execute computer systems validation activities associated with the decommissioning of laboratory equipment, instruments, and systems. This role ensures compliance with regulatory requirements and internal standards during retirement, archival, and documentation of assets and data within a GMP-regulated environment. Responsibilities Decommissioning Execution Generate and manage Change Controls related to laboratory decommissioning. Prepare and execute CSV Decommissioning Packages for equipment, instruments, and computerized systems. Coordinate final calibration and cleaning documentation for decommissioned assets. Manage CMMS retirement/inactivation documentation and update/deactivate assets in Maximo (equipment, instruments, computer systems). Review and archive preventive maintenance job plans, calibration records, and spare parts inventories. Collect and archive equipment/instrumentation manuals and technical documentation. Prepare and submit Finance Decommissioning documentation. Data Integrity & System Controls Perform system periodic assessment verification, audit trail reviews, and user access evaluations. Coordinate backup and archival of electronic data in compliance with data integrity standards. Review and update or retire SOPs, forms, and validation documents. Evaluate open records including Data Integrity Assessments, investigations, CAPAs, Infinity records, change controls, and change actions. Verify and remove hardware components as part of system retirement. Compliance & Documentation Coordinate closure of EHS-related change actions. Update and archive technical drawings associated with decommissioned assets. Compile and deliver turnover packages for final QA review. Ensure proper closure of change controls and documentation handoff. Qualifications Bachelor’s degree in Science or related field. Minimum 3 years of experience in CSV, QA, or laboratory systems within a regulated environment. Strong understanding of GMP, data integrity principles, and system lifecycle management. Experience with CMMS systems (e.g., Maximo), calibration documentation, and electronic data archival. Fluent in English and Spanish (spoken and written). Additional Information All your information will be kept confidential according to EEO guidelines.

Responsibilities

The CSV Specialist - Laboratory will lead and execute computer systems validation activities related to the decommissioning of laboratory equipment and systems. This role ensures compliance with regulatory requirements during the retirement and documentation of assets and data in a GMP-regulated environment.