JOB DESCRIPTION
Summary:
Performs routine lab work, sample analysis, and validation under limited supervision.
Education, Experience, and Skills Required:
- BA/BS or higher with 1-2 years lab experience; all experiences will be evaluated
- Able to perform basic 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
Essential Function:
- Prepare reagents, standards, and control samples
- Analyze samples using various techniques specific to department
- Perform method validation or qualification
- Operate analytical equipment
- 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
- Other tasks as assigned
Competencies:
- Adaptable
- Exactness
- Flexibility
- Collaborative
- Effective Listener and Communicator
- Results Driven
- Capacity to Learn
- Creative and Forward Thinking
- Initiative
- Supportive
- Initiate Assistance
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