Compounding Technician I 1st Shift

This position is a member of the Formulation Team. The Formulation Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs, ensure asepsis and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective and professional behavior is displayed at all times.

In conjunction with Production Management the Formulation Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The team member will be able to participate in all aspects of the Formulation Process. The Formulation Process includes dispensing, controlling and utilizing chemical raw materials in accordance with batch directions;

performing in-process QC sampling and on-site in process testing of pH, oxygen content, clarity, etc. during batch formulation; cleaning, assembling, sterilizing and collecting QC samples from small and large pieces of equipment in accordance with established production records, area cleaning and line clearances of the manufacturing equipment.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Utilizes scales, balances and load cells to weigh materials and perform batch additions of materials.
• Performs aseptic filtration setup and filter integrity testing.
• Utilizes blending, mixing and other homogenization technologies.
• Performs mass/concentration calculations to determine batch dosing in accordance with material potency.
• Stocks, gathers and stages manufacturing supplies and equipment as needed.
• Gathers, stages and returns production materials as needed.
• Cleans and stores manufacturing equipment and cleans areas as needed.
• Attends all training programs as required by Company SOPs, procedures and policies.
• Perform any other tasks/duties as assigned by management.

• High School Diploma or GED equivalent preferred. Associates degree in Chemistry or other science discipline is a plus.
• 1-3 years related field work experience is preferred.
• The manufacturing technology utilized at American Regent. – New Albany includes HMI-PLC/SCADA controlled Isolation Barrier, Autoclave Sterilization, CIP Sanitization and SIP Sterilization.
• Ability to take feedback constructively and function in a team-oriented work environment.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work overtime as needed.

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 50 pounds.
• Ability to meet and maintain cleanroom gowning requirements.
• Ability to meet and maintain respirator fit-testing requirements.