Summary: Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
- Reviews, edits and approves change controls, SOPs, reports and other documentation
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Trains/advises less experienced Specialists.
- Manages projects and prepares status reports.
- May be required to oversee contingent workers.
- Other duties assigned by management.
Knowledge Skills & Abilities:
- Ability to maintain integrity and honesty at all times
- Ability to work independently or as part of a team
- Ability to communicate with transparency
- Continuously drive to improve processes for improved performance
- Demonstrate respectful behavior at all times
- Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
- Gathers and organizes information
- Meets commitments on time
- Follows directions; performs well-defined tasks
- Effective time management skills
- Seeks to identify continuous improvement needs
Education and Experience:
- BS/BA in Engineering, Chemistry, or Life Sciences
- 3-5 years related experience for Specialist level
- 5+ years related experience for Senior Specialist level