Manufacturing Support Associate I/II

KBI Biopharma; North Carolina; On-site; USD 40,000 - 65,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Support Associate I/II to assist with cleaning and maintaining GMP facilities, manage process waste, and support all manufacturing operations.

The role requires a 12-hour shift schedule, aseptic and gowning qualifications, and strict record-keeping to comply with cGMPs and SOPs. The candidate will perform routine and nonroutine cleaning, manage waste streams, prepare PARs for production, stock supplies, and ensure safe handling of hazardous

Qualifications

• Manufacturing Support Associate I requires a high school diploma or associate degree with 0+ years' experience.
• Manufacturing Support Associate II requires a high school diploma or associate degree with 2+ years' experience.
• Clean room and waste handling, plus regulatory documentation experience is preferred.

Responsibilities

• Clean, operate, and maintain the GMP facilities and process waste areas.
• Prepare, build, and complete processing assemblies (PAR) for production.
• Complete facilities response forms and coordinate EM sampling if required.
• Stock general supplies in manufacturing production areas; handle hazardous and nonhazardous waste.

Skills

Documentation

Attention to detail

Safety procedures

Teamwork

Education

High School Diploma or Associate Degree

Tools

Word

Excel

Email

Computers

Job description

JOB SUMMARY

*Dayshift, 7am-7pm, 2-2-3 rotating schedule

The Manufacturing Support Associate I/II position is designed as an introduction to the environment of cGMP manufacturing. This position performs all routine/nonroutine 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.

JOB RESPONSIBILITIES

Responsibility of Time Performs and Maintains Manufacturing facilities by routine/nonroutine cleanings. 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.

JOB REQUIREMENTS

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

• Manufacturing Support Associate 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:

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.

The job requires working 12-hour shifts which may include working overnight. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.

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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.