Compounder

Job Summary

Responsible for the accurate weighing, checking and verification when mixing specific chemical compounds for product formulation. Performs monitoring of mixing and ancillary support equipment throughout formulation and filling. Routinely complies with cGMP's, departmental SOP's and company policies and maintains accurate documentation for each batch manufactured.

Responsibilities

• Performs set-up, operation and monitoring of tanks and mixing equipment for product formulation, including the use of PCS7 distributed control system for recipe execution.
• Weighs out and mixes precise amounts of chemicals according to specific formulas and monitors (verifies) product output from mixing operations. Responsible for the correct storage of raw materials (i.e. temperature requirements, nitrogen blanketing and moisture sensitive).
• Operates all formulation-related equipment (such as scales, pH meters, etc.).
• Performs operations necessary to adjust pH of product before releasing to production lines.
• Cleans and sanitizes equipment and chemical containers used in the product formulation process in accordance with SOP's.
• Performs daily, weekly and monthly department cleaning.
• Perform sanitization and operation of the WFI heat exchanger.
• Completes documents accurately when recording batch compounding, consumption of raw materials and cleaning activities.
• Initiates work orders to maintain equipment and facilitates continuous improvement.
• Strictly adheres to SOP's, cGMP's, safety requirements and company policies.
• Assists in the training of new employees and completes training on procedures in scheduled time frame.
• Perform accurate sampling of formulation and filling, hold time studies, taking dissolution samples, pressure readings and completing additional paperwork for products in development.
• Performs other duties and responsibilities as directed by supervision.