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Form of workJob Summary:
This individual will be responsible for aseptic sampling, coordination and QA release of Raw Materials and Consumables for new commercial biopharmaceutical manufacturing facility as well as subsequent cGMP manufacturing operations. Executes daily activities to assure timely inspection, sampling and release of Raw Materials and Consumables in collaboration with manufacturing and supply chain. Assists in execution and maintenance of the Raw Materials / consumables retain program. Maintains raw material sampling areas and locations in a compliant state. Support relevant investigations, change controls, CAPAs and raw material / consumable related projects. The individual provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Collaborates with manufacturing, supply chain and other internal stakeholders as needed to achieve site, operational and department goals. Cultivates and maintains Quality culture.
Job Responsibilities:
Minimum Requirements:
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
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.
This individual will be responsible for aseptic sampling, coordination and QA release of Raw Materials and Consumables for new commercial biopharmaceutical manufacturing facility as well as subsequent cGMP manufacturing operations. Executes daily activities to assure timely inspection, sampling and release of Raw Materials and Consumables in collaboration with manufacturing and supply chain. Assists in execution and maintenance of the Raw Materials / consumables retain program. Maintains raw material sampling areas and locations in a compliant state. Support relevant investigations, change controls, CAPAs and raw material / consumable related projects. The individual provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Collaborates with manufacturing, supply chain and other internal stakeholders as needed to achieve site, operational and department goals. Cultivates and maintains Quality culture.
Job Responsibilities:
- Performs compliant sampling, of Raw Materials and Consumables used for cGMP manufacturing. Assures activities comply with required procedures and cGMP requirements.
- Prepares cGMP documentation for sampling and testing of Raw Materials and Consumables, including documentation for testing by approved external contract laboratories. Track's status of samples, receives test results from contract laboratories and compiles documentation for final disposition.
- Ensures inventory accuracy within ASCtrac
- Maintains raw material sampling areas and equipment to required cleanliness classification and cGMP state. This includes execution of routine cleaning, non-routine cleaning and GMP audits.
- Support QA functional areas, manufacturing, and supply chain on material / consumable needs in support of manufacturing batch release and project timelines.
- Support relevant investigations, change controls, CAPAs and raw material / consumable related projects.
- Attends relevant operational meetings in support of Manufacturing operations and material / consumable disposition activities. Other activities as assigned by Management.
Minimum Requirements:
- High school diploma and two years of experience or one year of experience in a QC cGMP regulated environment within the Biopharmaceutical industry.
- Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
- Experience in QA inspection / release of materials for cGMP / commercial manufacturing, Quality Control and Raw Materials is beneficial.
- Knowledge of US and EU cGMP requirements is necessary.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
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.
