Manufacturing Support Associate I/II

KBI Biopharma; Durham (NC); On-site; USD 23,000 - 29,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC seeks a Manufacturing Support Associate I/II to support cGMP manufacturing. The role covers routine and non-routine cleanings, process waste management, and general facility upkeep. A 12-hour shift is required, with aseptic and gowning qualifications.

The successful candidate will document and maintain records to comply with regulatory requirements, SOPs, and policy documents while supporting manufacturing operations.

Qualifications

• High School Diploma or Associate Degree required.
• Aseptic and gowning qualifications required.
• Ability to document and maintain records to comply with regulatory requirements.

Responsibilities

• Performs and maintains manufacturing facilities by routine and non-routine cleanings (daily, weekly, monthly).
• Cleans, operates and maintains the Process Waste area and disposes waste materials accordingly.
• Prepares, builds and completes processing assemblies (PAR) for production.
• Stock general supplies in the manufacturing production areas and handle hazardous waste as needed.

Skills

Ability to read English

Communication with coworkers

Basic math skills

Education

High School Diploma or Associate Degree

Tools

Word

Excel

E-mail

Job description

Job Summary

Job Description :

The Manufacturing Support Associate I/II position is designed as an introduction to the environment of cGMP manufacturing. This position performs all routine/non routine cleanings of the GMP Facilities, manages Process Waste, and continuously supports the manufacturing operations. This position requires a 12-hour shift schedule. Aseptic and Gowning Qualifications are required for this position. Must be able to document and maintain records to comply with regulatory requirements, cGMP's, Policy Documents and SOPs.

Responsibility:

Performs and Maintains Manufacturing facilities by routine/non routine cleanings. (Daily, Weekly and Monthly Cleanings) - Requires Aseptic and Gowning Qualifications. Cleans, operates and maintains the Process Waste area. Ensures cleanliness of the area and discards waste materials within the area. Cleans drums and dollies as required. Prepare, build and complete processing assemblies (PAR) for production. Completes Facilities response forms and ensures communication to inform other departments requiring EM sampling if required. Stock general supplies in the manufacturing production areas. Handling and discarding of hazardous and nonhazardous waste.

Minimum Requirements :

• Level I: High School Diploma or Associate Degree with 0+ years of experience.
• Level II: High School Diploma or Associate Degree with 2+ years of experience.

Language Ability: Ability to read and interpret English documents such as safety rules, standard operating procedures, and procedure manuals. Ability to write routine reports and correspondence. Ability to communicate with coworkers and supervisors.

Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute ratio and percent.

Physical Demands: Must be able to stand, walk, wear steel toe shoes and have the ability to push, pull, squat, lift, reach and carry waste as needed, but not to exceed the Essential Physical functions of the job description.

Computer Skills: Word, Excel, E-mail

Equipment Use: Computer, Telephone, Copy and Fax Machine.

Working Conditions: Are there particular working conditions associated with this position that should be noted (i.e., working environment, hours of work, travel, workspace, etc.)? If yes, please explain: Due to the use of Spor-Klenz, respirators (full faced and half faced respirators) are required for the job description, facial hair needs to be maintained short enough to ensure a good seal to properly wear the respirator.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.