QA Specialist II/Senior Specialist

Position Summary:

This position is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in-process and stability test data. This position is also responsible for the review and approval of method qualifications and validations. Another responsibility is the review and approval of laboratory investigation and deviations associated with the laboratories.

Position Responsibilities:

• Performs compliance review on the following records: release, in-process, and stability data

• Responsible for the review and approval of method qualifications and validations

• Responsible for the review and approval of deviations and laboratory investigations

Minimum Requirements:

• For Specialist II: BS and 11+ years of experience or MS and 8+ years of experience in a GMP regulated environment within biopharmaceuticals or equivalent

• For Senior Specialist: BS and 14+ years of experience or MS and 11+ years of experience in a GMP regulated environment within biopharmaceuticals or equivalent

• Experience in QA review of analytical data (release, in-process, and stability)

• Experience in reviewing method qualifications/validations and the review and approval of laboratory investigations and deviations

• Knowledge of USP, EU and JP cGMP guidelines

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.