Compounder

Fresenius Kabi USA•Wilson, NC

1d•Onsite

About The Position

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.

Requirements

Accurate weighing, checking and verification when mixing specific chemical compounds for product formulation.
Monitoring of mixing and ancillary support equipment throughout formulation and filling.
Compliance with cGMP’s, departmental SOP’s and company policies.
Accurate documentation for each batch manufactured.
Set-up, operation and monitoring of tanks and mixing equipment for product formulation.
Use of PCS7 distributed control system for recipe execution.
Weighing out and mixing precise amounts of chemicals according to specific formulas.
Monitoring (verifying) product output from mixing operations.
Correct storage of raw materials (i.e. temperature requirements, nitrogen blanketing and moisture sensitive).
Operation of all formulation-related equipment (such as scales, pH meters, etc.).
Performing operations necessary to adjust pH of product before releasing to production lines.
Cleaning and sanitizing equipment and chemical containers used in the product formulation process in accordance with SOP’s.
Performing daily, weekly and monthly department cleaning.
Sanitization and operation of the WFI heat exchanger.
Accurate completion of documents when recording batch compounding, consumption of raw materials and cleaning activities.
Initiating work orders to maintain equipment and facilitates continuous improvement.
Strict adherence to SOP’s, cGMP’s, safety requirements and company policies.
Assisting in the training of new employees and completing training on procedures in scheduled time frame.
Performing accurate sampling of formulation and filling, hold time studies, taking dissolution samples, pressure readings and completing additional paperwork for products in development.

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.