Manufacturing Support Associate I/II

KBI Biopharma • Durham, NC

2d

About The Position

The Manufacturing Support Associate I/II position introduces employees to cGMP manufacturing. The role performs routine and non-routine cleaning of GMP facilities, manages process waste, and provides ongoing support to manufacturing operations. It requires a 12-hour shift schedule, aseptic and gowning qualifications, and accurate documentation in accordance with regulatory requirements, cGMPs, policy documents, and SOPs.

The position includes maintaining clean facilities and process waste areas, preparing and completing processing assemblies for production, supporting supplies and waste handling, and communicating with other departments when environmental monitoring sampling is required. Work may involve Spor-Klenz and requires use of full- or half-face respirators; facial hair must be short enough to ensure a proper respirator seal.

Requirements

• Level I: High school diploma or associate degree and 0 or more years of experience.
• Level II: High school diploma or associate degree and 2 or more years of experience.
• Aseptic and gowning qualifications are required.
• Ability to read and interpret English-language 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, push, pull, squat, lift, reach, and carry waste, within the essential physical functions of the job.
• Computer skills with Word, Excel, and email.
• Ability to use a computer, telephone, copy machine, and fax machine.
• Ability to wear full-face or half-face respirators; facial hair must be maintained short enough to ensure a proper seal.

Responsibilities

• Perform routine and non-routine cleaning of manufacturing facilities, including daily, weekly, and monthly cleaning.
• Clean, operate, and maintain the process waste area; maintain its cleanliness 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 sampling is required.
• Stock general supplies in manufacturing production areas.
• Handle and discard hazardous and nonhazardous waste.
• Document and maintain records to meet 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