Principal QA Specialist - Batch Disposition

KBI Biopharma • Durham, NC

4d

About The Position

Position Summary: Roles is responsible for performing, managing, and tracking deliverables for batch disposition to include compiling batch and batch linked documentation required for final and conditional product release, accurately maintaining site tracking and communication trackers, and providing accurate disposition statuses to clients, site departments, and Site / Executive Leadership. The role interfaces and collaborates with clients, Project Management, Manufacturing, QC, Supply Chain, Facilities/Engineering and internal QA departments to set disposition priorities, execute disposition elements and meet disposition timelines. Additionally, the role tracks, trends, and reports QA batch release metrics at relevant operational meetings and to Senior Leadership as well as leads internal cross-functional batch disposition meetings: identifying and tracking actionable items and escalating / informing to assure resolution of obstacles. Supports external client review and resolution of comments related to batch documentation, deviations, and CAPAs as needed. Responsible for gathering and presenting data for disposition and relevant metrics to management.

Requirements

• BS and 18+ years' experience or MS and 15+ years' experience in a cGMP regulated environment within Biopharmaceuticals or equivalent.
• Experience with Quality Systems to include batch record review, batch disposition of biopharmaceuticals, and investigations and CAPAs.
• Knowledge of US, EU, and Row cGMP guidelines required.

Responsibilities

• Tracks, monitors, and reports on status of Batch disposition for each product.
• Maintains and reports related to metrics.
• Trends, reports on batch disposition and other area data.
• Reviews batch documentation and approve relevant documents as the QA Approver.
• Compiles final packages.
• Works directly with Manufacturing, Engineering, MS&T (Manufacturing Science and Technology), Quality Control, Quality Assurance, Supply Chain and Validation to resolve issues to support commercial and clinical batch disposition.
• Interfaces with the client.
• Reviews deviations, CAPA’s, Interim Reports and ECs as needed.
• Completes Change Controls, master and executed Batch Records, and technical documents including CPV reports upon need.
• Initiates, manages Quality Change Controls as needed.
• Supports Annual Product Review, Complaint process (Supplier Quality, Product), Internal and client Inspections.
• Performs as disposition and complaint SME during regulatory and Health Authority Inspections.
• Performs as back-up for Client Support as a Point of Contact (POC), working closely with the PM team, attending client / KBI Quality to Quality meetings, compiles disposition and document status for meetings; develops related presentations.
• Supports manufacturing, Supply Chain and Quality to improve and streamline relevant Quality systems, business processes, and manufacturing processes.
• Executes other assignments upon request.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level