Compounder - 3rd shift

Job Summary

The compounding operator is responsible for the accurate weighing, checking and verification when mixing specific chemical compounds for product formulation in a Grade C / D or ISO 8 clean room environment. Performs monitoring of mixing and ancillary support equipment throughout formulation and filling and executes calibrations and preventive maintenance activities. Ensures compliance with cGMP's, departmental SOP's and company policies and maintains accurate documentation for each batch manufactured.

Hourly Rate : $25.17 / hour

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Responsibilities

• Performs set-up, operation and monitoring of tanks, and mixing equipment for product formulation. Including the use of valves, motors, shafts, heating and cooling lines, gas bubbling, sparging and blanketing
• Responsible for the accurate formulation of all production lots, both volumetrically and gravimetrically, disinfectants, stopper preparations and passivation solutions.
• 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).
• Calibrates and operates all formulation-related equipment (such as scales, pH meters, tanks, graduates, and pots etc.).
• Performs operations necessary to adjust and test 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 and fogging;
• Perform daily sanitization and operation of the WFI heat exchanger
• Fills out 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.
• Ability to use spectrophotometer, hygrometer, thermometer, scales, pH meter, conductivity meter, pfault tester, tachometer, dissolved O2 meter, Mokon Chiller and sonicator.
• Performs fault testing on glass lined tanks.
• Required to formulate cytotoxic materials which require specialized PPE, handling of waste, required to become baselined.
• Required to formulate antibiotics which require specialized PPE and handling of waste.
• Perform accurate sampling of formulation and filling, hold time studies, taking dissolution samples, pressure readings and completing additional paperwork for products in development.
• Ability to look ahead for tank constraints, compound bay availability, filling room status and raw material availability to assure timely supply of product to filling.
• Assumes other duties and responsibilities as directed by supervision.

Requirements

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution , andwellness program.

Fresenius Kabi is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.