JOB SUMMARY: This position performs analyses of materials, drug substances and drug products following cGMPs. Supports method development activities and perform method validations with supervision. Maintains and proposes improvements to lab quality systems. ESSENTIAL FUNCTIONS / RESPONSIBILITIES: Completed Analysis • Performs, interprets, evaluates, and records routine and some non-routine analytical lab tests of materials, drug substances and drug products following CGMPs. • Execute protocols, experiments as written. • Maintains instruments and equipment. Sets up instruments and conducts sample tests. Performs routine calibration of instrumentation. Ensures an adequate supply of test materials are available to perform daily testing. • Maintains and updates training records in a timely manner. Methods Validation • Supports method development/validation and method transfer activities. Problems Identified Resolved • Proactively identifies issues, communicates proposes/implements solutions. • Performs laboratory troubleshooting; proposes solutions, implements with direction. • Supports investigations, proposes solutions. Writes investigations with supervision. • Recommends and assists in implementation of improvements to procedures. Safe, Compliant, Efficient Labs • Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS E requirements, and FDA, DEA, USP, EP, and OSHA regulations. Trainees Demonstrate the Ability to Execute Analytical Processes • Implements training that ensures our ability to meet GMP, regulatory, and customer requirements and promotes first time right delivery. • Monitors the effectiveness of their training efforts and modifies approach to ensure achievement of learning objectives. • Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend an appropriate solution to performance problems. May support/provide input for investigations, troubleshooting, and method development/validation with supervision. Writes basic investigations with supervision.