MVQA Laboratory Systems Specialist

MV01-021326 QA Laboratory Systems Specialist

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas:
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

QA Laboratory Systems Specialist

As a QA Laboratory Systems Specialist, you will serve as the QA system owner for various laboratory computerized systems such as LIMS, Empower, and CDS. You will be responsible for ensuring that these systems remain validated and comply with FDA, cGMP, 21 CFR Part 11, and Data Integrity requirements. Your role will involve participating in system implementation, upgrades, patches, and configuration changes from a QA perspective.

• Bachelor's degree in a science-related field, preferably in Chemistry or a related discipline.
• Knowledge of computerized system validation (CSV) documentation.
• Familiarity with FDA regulations, cGMP guidelines, 21 CFR Part 11, and Data Integrity requirements.

• Oversee and approve change controls, deviations, CAPAs, and incident investigations related to laboratory systems.
• Perform periodic reviews of laboratory systems to ensure continued compliance and suitability for their intended use.
• Review and approve user access management for laboratory computerized systems.
• Support data integrity governance, including adherence to ALCOA+ principles for laboratory data.
• Review and approve SOPs, work instructions, and policies related to laboratory computerized systems.
• Assist in maintaining backup, recovery, disaster recovery, and business continuity plans for laboratory systems.

Work

Shifts:

1st shift with the possibility of working additional hours and weekends.