Blender Operator I

Job Responsibilities Manufactures blend batches with active drug substances and blend on a consistent basis. Leads a crew to coat blends and adhesives to produce laminate and perform the finishing operation on coated laminate. Assembles and disassembles all blending and manufacturing equipment. Weighs and documents the weights of raw materials, components, and product intermediates. Documents operational parameters and steps performed in the batch record. Performs batch record accountability calculations. Assists in training manufacturing Operator I’s throughout all manufacturing operations. Works with active drug products, adhesives, solvents, and various other chemicals to perform all steps in the manufacturing process. Documents operational parameters for manufacturing equipment. Complies with Current Good Manufacturing practices, SOPs and safety policies while performing all job duties. Maintains and cleans manufacturing and production areas and equipment and documents work performed in appropriate logbooks. Performs on-line coat weight sampling operations. Prepares finished or slit laminate rolls. Performs job tasks within production and other departments as needed. Works as a member of a team to achieve all outcomes. Operates in accordance with the Code of Conduct and Business Ethics and all established regulatory, compliance and safety requirements. Performs all work in support of the Values: Collaboration, Courage, Perseverance, and Passion. All other relevant duties as assigned. Qualifications Education High school diploma or GED plus a minimum of one year of related experience and/or training; or equivalent combination of education and experience. Knowledge, Skills and Abilities Ability to speak English effectively. Ability to write English and complete batch record documentation. Ability to read, understand and interpret documents such as safety rules, Standard Operating Procedures, batch records, and cleaning procedures. Ability to add, subtract, multiply, and divide all units of measure using whole numbers, common fractions and decimals. Ability to compute rate, ratio, percent, and plot and interpret data graphically. Ability to apply common sense understanding to carry out detailed written and oral instructions. Mechanical ability to assemble manufacturing equipment. Knowledge of FDA, DEA, cGMPs, and SOPs related to job requirements. Physical Requirements and Working Conditions The employee is regularly required to sit, stand and walk. The employee frequently uses hands and fingers, handles or feels; reaches with hands and arms; and talks and hears. The employee occasionally stoops, kneels, crouches or crawls. The employee frequently lifts and/or moves up to 50 pounds. The employee is regularly exposed to moving mechanical parts and frequently exposed to fumes or airborne particles and toxic caustic chemicals. The work area is usually loud. The employee may be required to wear a full‑face respirator and/or TYVEK or TYCHEM jumpsuits during cleaning operations, as well as eye protection, hearing protection and other PPE as required. The employee may work additional hours from time to time, including weekends. Shift hours may change due to operational needs. #J-18808-Ljbffr Aveva Drug Delivery Systems