Job Summary:
The incumbent will support GMP manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department.
The individual will support operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed.
The individual will support operations during the execution stage by tracking manufacturing records and logbooks in execution. They will also support manufacturing record and logbook reviews and track them through their postexecution 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.
The individual will ensure the manufacturing training plan is set appropriately and track training metrics and compliance for the department.
The individual will oversee the departmental compliance activities and metrics as it pertains to deviations, CAPAs, and change controls. They will initiate and complete deviations, CAPAs, and change controls, as needed, to support operations.
Lastly, the individual will author, train, and review manufacturing procedures as needed and perform additional duties as assigned.
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Minimum Requirements:
-Specialist I B.A./B.S. in a Life Sciences or Engineering degree and 2+ years relevant experience or HS Diploma and 6+ years of experience.
-Senior Specialist B.A./B.S. in a Life Sciences or Engineering degree and 9+ years of relevant experience or a HS Diploma and 13+ years of experience
Salary ranges:
Manufacturing Compliance Specialist I: $52,493 - $72,177.60
Senior Manufacturing Compliance Specialist: $103,600 - $142,450.
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
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.