Compounder Level 1

About the role

Preparing materials and equipment for formulation of liquid pharmaceutical products in accordance with FDA cGMP requirements. To mix ingredients as directed in batch record instructions to make liquid pharmaceutical products. To maintain cleanliness of facilities and equipment.

Responsibilities

• Follows all policies, procedures, SOPs, cGMPs, Work Instructions, and supervisor instructions. This duty is performed daily, about 100% of the time.
• Read batch record for batch to be produced and ask questions as needed to ensure understanding. This duty is performed daily, about 100% of the time.
• Prepare tank and equipment for batch production. Take pre-weighed materials to the batch production area. This duty is performed daily, about 50% of the time.
• Perform mixing operation according to instructions. This duty is performed daily, about 50% of the time.
• Record all process information on batch records and in logbooks. This duty is performed daily, about 100% of the time.
• Clean equipment and store properly. This duty is performed daily, about 50% of the time.
• Perform periodic department housekeeping activities per SOP. This duty is performed daily, about 20% of the time.
• Perform all functions in compliance with written company Standard Operating Procedures. This duty is performed daily, about 100% of the time.
• Notify management immediately upon discovery of any discrepancy or manufacturing problem. This duty is performed daily, about 100% of the time.
• Perform all duties following company safety procedures. This duty is performed daily, about 100% of the time.
• Accountable for accurate preparation of pharmaceutical products free from contamination in accordance with FDA cGMP requirements. This duty is performed daily, about 100% of the time.
• Perform any other related duties as required or assigned.

Requirements

• Ability to read and understand simple instructions, short correspondence, notes, letters and memos
• Ability to write simple correspondence.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals
• Ability to compute rate, ratio, and percent and to prepare and interpret bar graphs.
• Ability to use common sense understanding in order to carry out detailed written or oral instructions
• Ability to deal with problems involving a few known variables in situations of a routine nature.

Qualifications

• Mental alertness and adaptability to office and field area work routines
• Equivalent to four years of high school, with particular emphasis during high school in office skills, shop skills, or others, plus to 6 months related experience or training
• Or equivalent combination of education and experience.

Physical Requirements

• While performing the functions of this job, the employee is continuously required to stand, sit, reach with hands and arms, climb or balance; frequently required to walk, talk or hear; and occasionally required to use hands to finger, handle, or feel, stoop, kneel, crouch, or crawl.
• The employee must occasionally lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds, occasionally lift and/or