COMPOUNDER Details

COMPOUNDER

Fresenius Kabi - Grand Island, NY

Employment Type : Full-Time

Job Summary

The compounding operator is responsible for the accurate weighing, checking and verification when mixing specific chemical compounds for product formulation in a Class 100,000 clean room environment. Performs monitoring of mixing and ancillary support equipment throughout formulation and filling and executes calibrations and preventive maintenance activities. Routinely complies with cGMP’s, departmental SOP’s and company policies and maintains accurate documentation for each batch manufactured.

The compounding operator reports directly to the Formulation Supervisor. This position requires experience working in pharmaceutical, food or process related manufacturing environment; ability to accurately weigh measure and follow written direction and standard operating procedures. Additionally, this position requires good mechanical and trouble shooting skills and must be able to communicate and work in a team environment. The compounder operator directly interacts with Aseptic Control Operator Filler and Stopper Prep Operator to assure the timely delivery of formulated products.

Responsibilities

1. 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

2. Responsible for the accurate formulation of all production lots, both volumetrically and gravimetrically, disinfectants, stopper preparations and passivation solutions.

3. 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).

4. Calibrates and operates all formulation-related equipment (such as scales, pH meters, tanks, graduates, and pots etc.).

5. Performs operations necessary to adjust pH of product before releasing to production lines.

6. Cleans and sanitizes equipment and chemical containers used in the product formulation process in accordance with SOP’s.

7. Performs daily, weekly and monthly department cleaning and fogging;

8. Perform daily sanitization and operation of the WFI heat exchanger

9. Fills out documents accurately when recording batch compounding, consumption of raw materials and cleaning activities.

10. Initiates work orders to maintain equipment and facilitates continuous improvement.

11. Strictly adheres to SOP’s, cGMP’s, safety requirements and company policies.

12. Assists in the training of new employees and completes training on procedures in scheduled time frame.

13. Ability to use spectrophotometer, hygrometer, thermometer, scales, pH meter, pfault tester, tachometer, O2 meter, Mokon Chiller and sonicator.

14. Performs pfault testing on glass lined tanks.

15. Required to formulate cytotoxic materials which require specialized PPE, handling of waste, required to become baselined.

16. Required to formulate antibiotics which require specialized PPE and handling of waste.

17. Perform accurate sampling of formulation and filling, hold time studies, taking dissolution samples, pressure readings and completing additional paperwork for products in development.

18. 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.

19. Assumes other duties and responsibilities as directed by supervision.

REQUIREMENTS

1. Associates Degree or equivalent relevant work experience is preferred.

2. Must have 2 years minimum of experience working in pharmaceutical or related manufacturing environment.

3. Heavy lifting is required.

4. Must be willing to work overtime when necessary.

5. Must be trained and qualified in Personal Protective Equipment [PPE], i.e. respirators.

6. Must have good attention to detail, basic problem solving, communication and good documentation skills.

7. Mechanical troubleshooting ability a plus.

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 match, and wellness 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, disabilities, or protected veteran status.