Systems Validation Auditor (QA)
|Title:||Systems Validation Auditor (QA)|
|Job Status:||Full Time|
Celerion is searching for a full-time CSV Auditor to assure management that records, methods and practices are consistent with corporate policies, procedures and regulatory requirements. The emphasis of this position is relative to the validation of computerized systems.
- Ensure that computer validation activities are in compliance with internal procedures, policies, and applicable guidelines and regulations.
- Monitor computerized systems validation status.
- Perform vendor audits when applicable.
- Serve as consultant and provide expert opinions/related guidance regarding regulations pertaining to computerized systems to computer system users, developers and IT groups to support the implementation of systems.
- Evaluate proposed changes to computer systems to determine validation or revalidation requirements and the regulatory impact.
- Stay current with validation trends and global Celerion initiatives with regards to validation.
- Immediately advise manager of any significant issues regarding computerized system validation.
- Continuous improvement of processes.
- Bachelor’s degree in Computer Science, Business, Science or related field
- Clinical, data management, or training experience preferred for Clinical QA positions
- Knowledge of regulations (GxP, ISO, CFR Part 11)
- Computer software validation experience preferred
- QA experience preferred
- Excellent oral and written communication skills
- Ability to organize and manage multiple priorities
- Good time management skills.