KBI BioPharma
Manufacturing Compliance Specialist
KBI BioPharma, Durham, North Carolina, United States, 27703
The Manufacturing Compliance Specialist will support GMP manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department and provide support in the following:
Support Operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed. Support Operations during the execution stage by tracking manufacturing records and logbooks in execution. Support manufacturing record and logbook reviews and track them through their post-execution life cycle. The individual will monitor GDP execution and provide feedback, coaching, and training to ensure 'Right the First time' execution of manufacturing documentation. They will also track metrics for executed manufacturing records and logbooks throughout their entire lifecycle. Ensure the manufacturing training plan is set appropriately and track training metrics and compliance for the department. Oversee the departmental compliance activities and metrics as it pertains to deviations, capas, and change controls. Initiate and complete deviations, capas, and change controls, as needed, to support operations. Author, train, and review manufacturing procedures as needed and perform additional duties as assigned. Experience
Experience in production or quality assurance of GMP manufacturing is required. Experience working with electronic quality management systems such as documentation, deviations, capas, and change control systems is preferred. Experience working with electronic manufacturing records or logbooks is preferred. Experience working in biopharmaceutical manufacturing is preferred. • Excellent written and verbal communication skills are required. Strong attention to detail, as well as, presentation, written, and verbal communication skills required. Energetic, motivated and dynamic individual. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
Shift: M-F 7am-7p
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.
Support Operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed. Support Operations during the execution stage by tracking manufacturing records and logbooks in execution. Support manufacturing record and logbook reviews and track them through their post-execution life cycle. The individual will monitor GDP execution and provide feedback, coaching, and training to ensure 'Right the First time' execution of manufacturing documentation. They will also track metrics for executed manufacturing records and logbooks throughout their entire lifecycle. Ensure the manufacturing training plan is set appropriately and track training metrics and compliance for the department. Oversee the departmental compliance activities and metrics as it pertains to deviations, capas, and change controls. Initiate and complete deviations, capas, and change controls, as needed, to support operations. Author, train, and review manufacturing procedures as needed and perform additional duties as assigned. Experience
Experience in production or quality assurance of GMP manufacturing is required. Experience working with electronic quality management systems such as documentation, deviations, capas, and change control systems is preferred. Experience working with electronic manufacturing records or logbooks is preferred. Experience working in biopharmaceutical manufacturing is preferred. • Excellent written and verbal communication skills are required. Strong attention to detail, as well as, presentation, written, and verbal communication skills required. Energetic, motivated and dynamic individual. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
Shift: M-F 7am-7p
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.