Lab Analyst
Summary
The Lab Analyst samples and analyzes bulk and finished products, documents results, and releases product according to cGMP batch records, using standard analytical methods, laboratory instrumentation software, and Microsoft Office/365.
POSITION SUMMARY
The Lab Analyst is responsible for sampling, analyzing, documenting, and releasing product in accordance with batch record procedures, Standard Analytical Methods, specifications, cGMP requirements, and other assigned laboratory procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Collect, receive, and/or sample bulk and finished product for laboratory analysis in accordance with batch records and applicable procedures.
- Perform routine/basic analytical testing by following Standard Analytical Methods and product specifications.
- Prepare reagents, perform required calculations, and ensure materials used are within expiration.
- Use laboratory equipment, instrumentation software, and Microsoft Office/365 applications as required.
- Perform or assist with required calibrations, verifications, documentation checks, and equipment records for scales, scanners, meters, and other assigned equipment.
- Maintain accurate lab notebooks, logbooks, batch record documentation, reserve inspection records, retention skids, and related logs.
- Review or audit lab notebooks, logbooks, batch records, and related documentation as assigned.
- Release bulk product to filling and assist with final product release activities in accordance with applicable procedures.
- Maintain proper cleanliness, use required PPE, clean laboratory work areas and glassware, and follow laboratory safety and quality requirements.
- Follow other assigned laboratory and quality procedures and perform other tasks as trained and assigned.
- High school diploma or equivalent required.
- Science-related college degree, such as Biology or Chemistry, preferred but not required.
- Previous cGMP experience preferred but not required.
- General safety knowledge and ability to follow safety requirements.
- Extreme attention to detail and ability to follow instructions exactly.
- Computer software and Microsoft Office/365 skills required.
QUALIFICATIONS
WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS
Work is performed in chemistry laboratory, manufacturing/production, and office settings. The role requires compliance with safety, quality, GMP, sanitation, and PPE requirements and may involve standing, walking, climbing stairs, accessing production equipment, and connecting or disconnecting hoses during lab, batching, filling, or plant trial activities.
Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.