Manufacturing Support Associate I/II

KBI Biopharma, Inc.; North Carolina; On-site; USD 52,000 - 76,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Support Associate I/II to support cGMP manufacturing. The role focuses on routine and non-routine cleanings of GMP facilities, process waste management, and ongoing operations support on a 12-hour shift.

Aseptic and gowning qualifications are required, and candidates must document and maintain records per regulatory requirements and SOPs. The position involves preparing processing assemblies (PAR), stocking supplies, and handling hazardous waste in

Qualifications

• High school diploma or associate degree is required.
• Aseptic and gowning qualifications are required.
• Must be able to document and maintain records per regulatory requirements (cGMP, SOPs).
• Experience with process waste handling is a plus.

Responsibilities

• Performs and maintains manufacturing facilities by routine and non-routine cleanings (daily, weekly, monthly).
• Cleans, operates, and maintains the Process Waste area; discards waste materials.
• Prepares, builds, and completes processing assemblies (PAR) for production.
• Completes facilities response forms and communicates EM sampling needs to other departments.
• Stocks general supplies in the manufacturing production areas.
• Handles and discards hazardous and nonhazardous waste.

Skills

Aseptic procedures

Gowning qualifications

Record/documentation

Waste management

Basic computer skills

Education

High School Diploma or Associate Degree

Tools

Word

Excel

Email

Job description

Job Summary

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.

Responsibilities

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

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.

EEO/AA Statement

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.

About KBI

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.