QA Specialist II - Deviations & CAPAs

Position Summary:

Responsible for supporting the coordination, tracking, and trending, of Deviations and CAPAs. Review and approval of manufacturing exceptions (Deviations and CAPAs) in support of GMP manufacturing operations. Support Manufacturing QA departmental responsibilities to include review of batch records and/or raw materials release as needed.

Position Responsibilities:

• Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner. Review and approve Deviations and CAPAs.

• Supports the generation of metrics, trends, and project specific status updates of Deviations and CAPAs.

• Support review of manufacturing batch records and log books for on-going manufacturing operations as needed.

• Collaborate with functional areas to improve the Deviation/CAPA system, to include support in development of training materials and training personnel.

• Attend relevant operational and project meetings. Support client audits and regulatory inspections as required.

Minimum Requirements:

• BS in scientific field with 8+ years’ experience or MS and 5+ 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.

• Proficient in Project Management with knowledge of US, EU and Row cGMP guidelines.

Salary Range: $66,966 – $92,077

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.