Compounding Technician II; 3rd Shift

This position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. They ensure aseptic 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 Manufacturing 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 Compounding Process. The Compounding Process includes dispensing of raw material, sterile dispensing of raw material (Hilliard Facility), compounding, sterile compounding (Hilliard Facility), sterile filtration, 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., cleaning, assembling, and sterilizing small and large pieces of equipment, and the tear-down and line clearances of the manufacturing equipment. The Compounding Process will be performed in accordance with established production records and company SOPs in a concerted effort to manufacture sterile liquid pharmaceuticals. The Team Member will be proficient in all activities associated with the compounding process and be able to work with minimal supervision.

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

• Proficient in all activities associated with the compounding process and be able to work with minimal supervision, will receive direction, training, and mentorship from the Senior Compounding Technicians.
• The Team Member will, with assistance from Senior Team Member/s, be able to troubleshoot minor equipment adjustments or machine diagnostics and repairs during setup and during, operation. and as needed.
• Utilizes scales, balances, and load cells to weigh materials and performs batch additions of materials. Utilizes blending, mixing and other homogenization technologies.
• Performs aseptic filtration setup and filter integrity testing and 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. Assist all team members with equipment assembly and cleaning as required to support manufacturing activities.
• Physically performs compounding activities as defined by established operating procedures and as directed by Supervisor.
• Physically performs compounding related tests (daily performance verifications, pH measurements, dissolved oxygen content, filter testing, etc.)
• Ensure that only approved documentation and procedures are utilized.
• Oversee production supply, materials as needed.
• Cleans and stores equipment gathering and staging activities required to support manufacturing. Assisting with equipment and cleans areas as needed operating supply inventory control.
• Attends all training programs as required by Company SOPs, procedures, and policies.
• Assists in Training new employees on compounding and dispensing raw materials as well as equipment cleaning procedures.
• Is proficient in dispensing raw materials using balances/scales both inside and out of the Formulation Isolator, as well as direct charge into the vessel in accordance with SOPs.
• Reviews logbooks and batch documentation for…