Key Responsibilities
? Perform routine and non-routine laboratory analyses on samples
? Record, analyze, and report test results in accordance with standard operating procedures (SOPs)
? Ensure compliance with internal quality standards and regulatory requirements (e.g., FDA, ISO, GMP, as applicable)
? Prepare samples, reagents, and laboratory equipment for testing
? Coordinate sample testing with external laboratories
? Calibrate and maintain laboratory instruments and equipment
? Identify and report out-of-specification (OOS) results or deviations
? Assist in investigations and root cause analysis for quality issues
? Maintain accurate and organized lab documentation and records
? Follow safety protocols and maintain a clean, organized laboratory environment
? Support audits and inspections as needed
Qualifications
? Associate’s or Bachelor’s degree in Chemistry, Biology, Microbiology, or a related field
? 2–3 years of laboratory experience, prior cGMP experience preferred
? Familiarity with laboratory techniques and analytical instruments
? Working knowledge and experience with Waters HPLC and Empower Software or equivalent
? Knowledge of quality systems and regulatory standards is a plus
? Strong attention to detail and organizational skills
? Basic computer skills (e.g., Microsoft Office, LIMS systems)