Summary: The Compounding Technician supports timely manufacturing of parenteral cGMP products in an aseptic environment. Essential Duties and Responsibilities: Set up, operation, sanitization and sterilization of equipment and manufacturing areas Prepare, wash, and sterilize vials; complete batch calculations, preparation, and formulations Compound bulk solution of product using costly materials in raw bulk including hazardous chemicals such as cytotoxins, carcinogens, mutagens, teratogens, acids, bases, and flammable liquids and gases Prepare and complete all paperwork associated with compounding while observing aseptic manufacturing practices Clean compounding formulation equipment/vessels, maintain general cleanliness of area and equipment to ensure optimal operation and aseptic production Operate compounding equipment and compound bulk solutions Perform all compounding calculations: batch record calculations for final batch weight, API amount required, basic metric conversions, and weigh and measure raw materials Assemble and prepare equipment and materials for compound ensuring certificate of analysis is obtained for materials used and checked against requirements of MBRs Prepare and complete paperwork connected with the compounding process including incident reports, SOPs Complete inventories, order equipment and supplies, and stock gowning cabinets Dispose of hazardous chemicals and flammable wastes in compliance with EH&S guidelines and cGMP regulations Other duties as assigned Supervisory Responsibilities: This job has no supervisory responsibilities. Education and/or Experience: High school diploma or general education degree (GED); with a minimum 2 years relevant experience in production, manufacturing, clean room or chemistry environment. Associate’s degree or 2 years college preferred. Pharmaceutical experience preferred. Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write clearly and speak effectively. Mathematical Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Computer Skills: Proficient in the use of MS Word, Excel, Outlook and Access. Must be able to learn manufacturing software. Other Qualifications: Must pass background check Must pass drug screen and physical Must pass Wonderlic Basic Skills Test at 12th grade level or above Physical Demands: While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to handle or feel.
The employee is occasionally required to stand, walk, reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception. Work Environment: While performing the duties of this job, the employee is regularly exposed to fumes or airborne particles and toxic or caustic chemicals.
The employee is frequently exposed to moving mechanical parts; high, precarious places; risk of electrical shock; explosives; risk of radiation and vibration. The employee is occasionally exposed to wet and/or humid conditions; extreme cold and extreme heat. The noise level in the work environment is usually moderate. Note This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position.
Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently.
Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.