Position Summary:

The MQA Supervisor/Senior Supervisor is responsible for leading the MQA batch record review team.  Responsible for the review, approval and posting of manufacturing batch records, internal support records, and related client records.  Supervisor level loads work across the group and coordinates the support for external client reviews and timely resolution of comments.  They will collaborate directly with the MQA Floor Support and Manufacturing teams to complete timely reviews and support dispositions. They are to collaborate with Manufacturing on team initiatives and provides ongoing feedback in order to improve overall efficiency. The MQA Supervisors is responsible for coaching and mentoring their teams as needed to foster a GMP compliant site. 

As part of a GMP Contract Manufacturing Organization. MQA Supervisors are expected to provide sound guidance to internal MQA team and customers with respect to batch record review process. The MQA Supervisor’s team shares responsibility for the inspection readiness of the site.  

Position Responsibilities:

• Performs and coordinates the compliance review of master batch records, executed batch records, and internal support records.  Maintains timely resolution of batch record comments for Manufacturing and Clients.  
• Responsible for coordination and tracking of all records from review to closure.  Documents and reports out metrics to relevant operational meetings as needed.
• Collaborates with functional areas to improve cycle time for batch record review and subsequent disposition.
• Attends relevant operational meetings in support of record disposition.
• Develops and supports training program for QA review of batch records.  Provide oversight of training and certification to staff.
• Supports department related Deviations and CAPAs
• Supports Client Audits and Regulatory Inspections as area Subject Matter Expert.

Minimum Requirements:

BS and 6+ or MS and 4+ years’ experience (Supervisor), BS and 8+ or MS and 6+ years’ experience (Senior Supervisor) experience in a QA or cGMP environment in Biopharmaceuticals or equivalent. Experience in QA Batch Record review and disposition and/or related Quality Systems, with 1-3 years of supervisory experience. Prefer experience in providing QA shop floor support or prior MFG experience, facilitating real-time reviews, guiding the MFG team in compliant documentation.  Demonstrates strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution skills. Strong understanding of FDA, EU, and ROW cGMP regulations.

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.