Supervisor, Quality Assurance

KBI Biopharma • Durham, NC

4d

About The Position

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.

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.
• Strong understanding of FDA, EU, and ROW cGMP regulations.
• Demonstrates strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution skills.

Nice To Haves

• Prefer experience in providing QA shop floor support or prior MFG experience, facilitating real-time reviews, guiding the MFG team in compliant documentation.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees