What are the responsibilities and job description for the Manufacturing Associate I/II - Support position at KBI Biopharma?
Position 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, Process Waste, and continuously supports the manufacturing operations. This position requires a shift schedule(7pm-7am)(2-2-3). 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.
Position Responsibilities
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.
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, Process Waste, and continuously supports the manufacturing operations. This position requires a shift schedule(7pm-7am)(2-2-3). 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.
Position 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.
- Order and stock general supplies in the manufacturing production areas.
- Operates autoclave for sterilization of material and equipment as needed for production.
- Handling and discarding of hazardous and nonhazardous waste.
- Manufacturing Support Associate I: High School Diploma or Associates Degree with 0 years of experience
- Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 2-5 years’ experience related GMP manufacturing operations; or high school diploma with 4-6 years’ experience in a related GMP manufacturing operation
- 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.
- 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.
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.
