What are the responsibilities and job description for the Validation - Validation Specialist position at Omni Inclusive?
Senior Validation Specialist
Warren, NJ Onsite
Work Schedule : Mon - Fri, Business Hours
The Senior Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include : qualification of laboratory instruments, setup of computers and instruments, troubleshooting of system related issues, and technical writing and execution. Executes validation projects, system qualification, and implements industry best practices for the design and delivery of GxP computerized systems.
1. Required Competencies : Knowledge, Skills, and Abilities :
- Working understanding of validation concepts and requirements.
- Intermediate written and verbal communication skills.
- Knowledge of cGMP.
- Critical reasoning and decision making skills.
- Knowledge of validation industry and regulatory requirements.
- Ability to work independently and participate in a team.
- Work and time management skills.
- Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.
2. Duties and Responsibilities :
Performs validation document generation, program management, and protocol execution activities.
Protocol execution and project activities.
Performs general administrative and organizational activities.
Perform other tasks as assigned.
3. Education and Experience :
4. Working Conditions
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
