Responsibilities
- 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
- 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
- Review and evaluate data results
- Train lower level Scientists
- Other tasks as assigned
Skills, Education & Qualifications
- BA/BS or higher with 4-6 years lab experience; all experiences will be evaluated
- Able to perform complex lab work
- Experience working in a regulated environment
- CRO experience preferred
- ELISA, MSD experience or pipetting efficiency needed
- Ligand binding/ immunoassay experience
- 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
