Principal Quality Compliance Specialist Deviations and Client Support

Job Summary:
Responsible for review and approval of Deviations and CAPAs in support of GMP manufacturing operations and other functional groups as required (e.g. Facilities Engineering, IT, Supply Chain, etc.). Support timely review of events for classification, initiation in EtQ and closure. Mentors junior QA staff in deviation/CAPA review and approval to include training and certification of QA approvers. Provide metrics to management as requested.

Job 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. Reviewand approve Deviations and CAPAs. Classifies deviations and assists in leading daily triage meetings.
• Works directly with manufacturing, facilities, and other departments responsible for GMP activities to support resolution of deviations and other compliance issues in a timely manner in support of batch release activities. Provides training for Deviation and CAPA TRNs to KBI staff.
• Collaborate with functional areas to improve the Deviation/CAPA system to include support in development of training materials and training personnel. Works to streamline these processes.
• Supports the generation of metrics, trends and project specific status updates of Deviations and CAPAs.
• Notifies the Client of deviations. Supports external client review and resolution of comments for assigned deviations and related CAPAs as needed.
• Attend relevant operational and project meetings. Support client audits and regulatory inspections as required.

Minimum Requirements:

• Minimum BS in scientific field with 14+ years’ experience or MS and 11+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent. Experience with Quality Systems to include Batch Record review, supporting investigations and CAPAs. Knowledge of US, EU and Row cGMP guidelines required.

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.