- Prepare reagents, standards, and control samples
- Analyze samples using various techniques specific to department
- Assist with method development
- Perform method validation or qualification
- Operate analytical equipment
- Lead troubleshooting activities
- Maintain analytical equipment
- Ensure lab area is clean and inspection ready at all times
- Record tasks in accordance with Good Documentation Practices (GDP)
- Understand and apply regulatory requirements; GLP, GCP, 21CFR Part 11
- Follow applicable SOPs and procedural documents
- Review and evaluate data results
- Train lower level Scientists
BA/BS or higher in chemistry with 5-6 years lab experience; all experiences will be evaluated
- Able to perform complex lab work including LCMS
- Able to work in a regulated environment
- Able to work effectively and contribute within a team
- Able to work with computer systems & able to document clearly
- Knowledge of and experience in a regulatory environment
Independently performs routine lab work, sample analysis, validation, and method development
