Manufacturing Support Associate I/II

KBI Biopharma • Durham, NC

4d

About The Position

The Manufacturing Support Associate I/II role introduces employees to cGMP manufacturing. The position performs routine and non-routine cleaning of GMP facilities, manages process waste, and provides ongoing support to manufacturing operations. A 12-hour shift schedule is required, as are aseptic and gowning qualifications. The associate must document and maintain records in compliance with regulatory requirements, cGMPs, policy documents, and SOPs.

The role also involves preparing, building, and completing processing assemblies for production; stocking general supplies in manufacturing areas; and handling hazardous and nonhazardous waste. Because Spor-Klenz is used, full-face or half-face respirators are required. Facial hair must be kept short enough to ensure a proper respirator seal.

Requirements

• Level I: High school diploma or associate degree; 0 or more years of experience.
• Level II: High school diploma or associate degree; 2 or more years of experience.
• Ability to read and interpret English-language documents, including safety rules, standard operating procedures, and procedure manuals.
• Ability to write routine reports and correspondence and communicate with coworkers and supervisors.
• Ability to follow written, oral, or diagrammed instructions and address problems involving several concrete variables in standardized situations.
• Ability to perform basic arithmetic using whole numbers, common fractions, and decimals, and compute ratios and percentages.
• Ability to stand, walk, wear steel-toe shoes, and push, pull, squat, lift, reach, and carry waste, within the job's essential physical functions.
• Ability to use Word, Excel, and email.
• Ability to wear full-face or half-face respirators; facial hair must be short enough to provide a proper respirator seal.

Responsibilities

• Perform routine and non-routine cleaning of manufacturing facilities, including daily, weekly, and monthly cleaning.
• Maintain aseptic and gowning qualifications required for the work.
• Clean, operate, and maintain the process waste area; keep the area clean and discard waste materials.
• Clean drums and dollies as required.
• Prepare, build, and complete processing assemblies (PAR) for production.
• Complete Facilities response forms and communicate with other departments when environmental monitoring (EM) sampling is required.
• Stock general supplies in manufacturing production areas.
• Handle and discard hazardous and nonhazardous waste.
• Document and maintain records in compliance with regulatory requirements, cGMPs, policy documents, and SOPs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED