Jobs 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.

Operate a multi-line phone system to answer and route calls, greet visitors, manage incoming/outgoing mail, perform filing and data entry for store orders, process payments and balance the register, and maintain a professional front office environment while supporting departmental tasks as requested.

Perform and lead analytical laboratory testing of raw materials and finished goods using HPLC, GC, LC-MS and other instruments. Coordinate sample flow, troubleshoot and maintain equipment, assist method development, review data for material dispositions, train and mentor junior analysts, support cGMP compliance, and coordinate projects and lab staffing to meet turnaround metrics.

Oversee granulation production activities including mixing, milling, granulating and drying. Coordinate with shift supervisor, ensure GMP and safety compliance, train operators, prioritize job orders, lead improvement and safety meetings, manage attendance and performance reviews, and ensure timely completion and quality of tablet, capsule, and powder formulations.

Perform laboratory analyses of raw materials and finished products using chromatography, spectroscopy, and microbiological methods; maintain and calibrate instruments; assist with OOS investigations, cGMP compliance, data entry, SOPs, method validation, inventory, and cross-functional QC activities. Train and eventually certify peers.

Oversee on-site IT operations and helpdesk, supervise staff, manage ticket SLAs, vendors, IT budget, SOPs, projects, systems upgrades, and provide technical leadership.