Blender Operator I

Key Responsibilities

• Manufactures blend batches with active drug substances and blend on a consistent basis.
• Assembles and disassembles all blending and manufacturing equipment.
• Weighs and documents the weights of raw materials, components, and product intermediates.
• Follows all Batch Record and SOP instructions and completes all relevant documentation as required.
• Documents operational parameters and steps performed in the batch record.
• Performs batch record accountability calculations.
• Works with active drug products, adhesives, solvents and various other chemicals to perform all steps in the manufacturing process.
• Complies with Current Good Manufacturing practices, Standard Operating procedures and safety policies while performing all job duties.
• Wear appropriate personal protective equipment for blending or manufacturing tasks being performed.
• Maintain all blending and kettle storage rooms in a clean and organized manner.
• Documents work performed in appropriate logbooks.
• Performs on-line coat weight sampling operations.
• 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 our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our corporate values: Innovate, Evolve and Excel.
• All other relevant duties as assigned.

Qualifications

Education: Highschool diploma or general education degree (GED)

Experience: Minimum of 1 year of related experience and/or training in Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required; or equivalent combination of education and experience.

Knowledge, Skills and Abilities

• An individual must be able to perform each essential job function satisfactorily.
• Ability to read English and interpret documents such as safety rules, Standard Operating Procedures batch records and cleaning procedures.
• Ability to write in English and complete batch record documentation.
• Ability to speak English effectively.
• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.
• Ability to compute rate, ratio, percent and to plot and interpret data graphically.
• Ability to apply common sense understanding to carry out detailed written and oral instructions.
• General mechanical ability to assemble manufacturing equipment.
• Knowledge of FDA, DEA, cGMPs, and SOPs related to job requirements

Physical Requirements and Working Conditions

• While performing the duties of this job, the employee is regularly required to sit, stand and walk. The employee is frequently required to use hand to finger, handle or feel; reach with hands and arms; and talk and hear. The employee is occasionally required to stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 50 pounds.
• While performing the duties of this job, the employee is regularly exposed to moving mechanical parts. The employee is frequently exposed to fumes or airborne particles and toxic caustic chemicals. The noise level in the work area is usually loud.
• The employee will be required at times to wear a full face respirator and/or TYVEK or TYCHEM jumpsuits during cleaning operations, as well as eye protection, hearing protection and other personal protective equipment (PPE) as required. The employee may be required to work additional hours from time to time, including weekends. Shift hours are subject to change due to operational needs.