Microbiology Data Reviewer/Specialist I

Position Summary :

Reviews data associated with method verifications / validations / qualifications of microbiological methods and testing of in-process and drug substance / product samples. Ensures high quality assessment of tests and investigations, timely review and release of results and maintenance of the electronic environmental monitoring program. Assists with trending of Environmental Monitoring data.

Position Responsibilities :

• Reviews data and reports associated with development and qualification of microbiological methods and testing of in-process and drug substance / drug product samples.
• Verifies that calculations and documented information is present complete and accurate.
• Verifies that all analyses are performed per methodology and are in compliance with GMP requirements, when applicable.
• Understands assays used to develop methods and / or test samples.
• Trains on Microbiology / ES assays and is able to perform assays when needed.
• Responsible for developing a current understanding of cGMP and other regulatory requirements.

Minimum Requirements :

B.S. degree and 8 years of related experience; M.S degree and 6 years of related experience; or Ph.D. in a related discipline. Able to react to change productively and handle other essential tasks as assigned. Adheres to all safety 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.