United Spinal Association Jobs

Nature and Scope The Compounding Technician Lead is a member of the Formulation Team, responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The Formulation team ensures asepsis and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective, and appropriate behavior is displayed at all times. The Formulation Team also provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting company goals. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Physically performs and oversees compounding activities as defined by established operating procedures and as directed by Manager/Supervisor. Physically performs and oversees compounding related tests (daily performance verifications, pH measurements, dissolved oxygen content, filter testing, etc.) Ensures equipment and supply inventories are maintained and available for use in accordance with production schedules. Ensures only approved materials, equipment, documentation, and procedures are utilized at all times. Ensures that personnel do not perform tasks for which they do not have accurate and approved training records. Ability to perform machine diagnostics and repairs as required. Provides mentorship and training to junior members of the Compounding team. Physically performs and oversees ingredient dispensing, mixing, in-process testing during compounding and provides documentation oversight for such activities. Attends all training programs as required by Company SOPs, procedures, and policies. Participate in all aspects of the Formulation Process , including 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, also area cleaning and line clearances of the manufacturing equipment. Responsible for the proper use of batch documentation. Troubleshoot most of the compounding process and equipment and where necessary make adjustments and minor repairs during set up and during operations. Acts as the Supervisor in the Supervisor's absence. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School Diploma or GED equivalent required. Associate's or bachelor's degree in chemistry or related science discipline is a plus. Minimum of one year experience as Compounding Technician II or above having performed at or above a satisfactory level, or minimum 3 years work experience in a relevant field preferred. 1 year experience in a training role required. Experience with manufacturing technology such as HMI-PLC/SCADA controlled Isolation Barrier, Autoclave Sterilization, CIP Sanitization and SIP Sterilization preferred. Ability to work in an environment where chemicals are handled and dispensed daily. Excellent chemical handling and mathematical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment. Ability to meet and maintain Class 100 Certification for sterile compounding/transfer (Hilliard facility) as well as maintain cleanroom gowning and respirator fit testing re