Job Description:
Performs and leads complex lab work, sample analysis, validation, and method development with limited supervision.
Responsibilities
- Prepare reagents, standards, and control samples
- Analyze samples using various techniques specific to department
- Perform complex method development with limited supervision
- Perform method validation or qualification
- Operate analytical equipment
- Lead troubleshooting activities; assays and equipment
- Maintain analytical equipment
- Review, evaluate, and interpret data results
- Draft and present posters/presentations
- Train and mentor lower level Scientists
- Collaborate with clients and vendors
- Ensure lab area is clean and inspection ready at all times
- Remove lab waste
- 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
- Other tasks as assigned
Education, Experience & Skills Required
- BA/BS or higher with 7-8 years lab experience; all experiences will be evaluated
- Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
- Able to independently perform complex lab work
- 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