Teams at Threshold Enterprises

Performs laboratory testing and analysis of raw materials, finished goods, pilot products, and vendor samples using analytical and microbiological techniques. Assists with instrumentation troubleshooting, calibration, out-of-specification investigations, GMP compliance, method validation, quality improvement, complaint investigations, data review, reporting, SOP writing, inventory maintenance, and peer training.

Performs analytical chemistry and microbiology testing, method development and validation, data analysis, documentation, equipment troubleshooting, and quality investigations in a cGMP laboratory. Leads and trains junior analysts, supports SOP and process improvements, reviews and releases test results, coordinates instrument qualifications and calibrations, and collaborates with Quality, Research and Development, Planning, and management on audits, CAPAs, and out-of-specification investigations.

Evaluates raw material and finished-product test results, specifications, supplier documentation, and Certificates of Analysis for acceptability and cGMP compliance. Processes, releases, or rejects materials; manages records in Microsoft Dynamics Navision; investigates expired materials; supports supplier qualification, audits, corrective actions, documentation review, waste sorting, team training, and continuous improvement. The role requires careful adherence to SOPs, safety procedures, and Good Documentation Practices in an on-site production environment.