Principal QA Specialist - Deviation Reviewer

Position Summary:

This position is primarily responsible for supporting the coordination, tracking, and trending, of Deviations and CAPAs associated with the AFS (testing) department in a contract manufacturing organization. This position is also responsible for the review and approval of release, in-process and stability test data. Experience in the review and approval of method qualifications and laboratory investigations is also beneficial to this position.

Position Responsibilities:

• Works directly with the AFS(testing group), QA and other departments responsible for GMP activities to resolve related deviations and other compliance issues in a timely manner.

• Responsible for the review of release, stability data and in-process data.

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

• Responsible for the review of laboratory investigations.

Minimum Requirements:

• BS in scientific field with 18+ years’ experience or MS and 15+ years’ experience in a QA cGMP regulated environment within biopharmaceuticals or equivalent.

• Experience with quality systems to include deviation investigations management as investigator and/or QA approval role and developing/managing CAPAs. Knowledge of US and EU guidelines is a plus.

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.