QA Specialist - Raw Materials

KBI Biopharma • Durham, NC

5d

About The Position

The Specialist, Quality Assurance Raw Materials (QARM) is responsible for quality assurance activities associated with the sampling, review, qualification, and disposition of raw materials and consumables supporting both clinical and commercial biopharmaceutical manufacturing operations. This role provides quality oversight within a cGMP-regulated environment and supports supplier quality management, material release activities, investigations, change controls, and continuous quality improvement initiatives. The Specialist collaborates cross-functionally with Manufacturing, Supply Chain, Warehouse Operations, Quality Control, and external suppliers to ensure the timely availability and compliance of materials used in biopharmaceutical production while maintaining the highest standards of product quality and regulatory compliance.

Requirements

• Quality assurance activities associated with the sampling, review, qualification, and disposition of raw materials and consumables
• Quality oversight within a cGMP-regulated environment
• Support supplier quality management, material release activities, investigations, change controls, and continuous quality improvement initiatives
• Collaborate cross-functionally with Manufacturing, Supply Chain, Warehouse Operations, Quality Control, and external suppliers
• Ensure timely availability and compliance of materials used in biopharmaceutical production
• Maintain the highest standards of product quality and regulatory compliance
• Review and approve specifications, policies, procedures, and other quality documentation related to raw materials and consumables
• Review change controls and assess potential quality and regulatory impact
• Review vendor change notifications and determine potential impact to manufacturing processes in partnership with subject matter experts
• Ensure compliance with cGMP requirements, internal procedures, and regulatory expectations
• Provide quality oversight of raw material release activities supporting clinical and commercial manufacturing operations
• Partner directly with vendors, suppliers, and internal stakeholders to facilitate timely release and disposition of materials based on manufacturing schedules and customer forecasts
• Support supplier qualification activities, supplier quality investigations, and supplier performance monitoring initiatives
• Provide QA support and oversight for deviations, investigations, CAPAs, and change controls initiated in or impacting the QA Raw Materials Department, Warehouse Operations, and incoming material processes
• Participate in root cause investigations and support implementation of effective corrective and preventive actions
• Ensure quality events are completed in accordance with site procedures and regulatory requirements
• Collaborate with Supply Chain, Procurement, Warehouse Operations, Manufacturing, and Planning teams to ensure continuity of material supply while maintaining compliance
• Provide quality oversight and risk assessments for material shortages, supplier performance concerns, inventory management activities, material planning decisions, and expedited material requests
• Support business continuity efforts through proactive management of supplier and material-related quality risks
• Maintain raw material retains, client cell bank inventories, and client drug substance retains
• Manage inventory location assignments and tracking within applicable electronic systems
• Support inventory reconciliation activities and ensure proper storage, traceability, and control of retained materials

Responsibilities

• Review and approve specifications, policies, procedures, and other quality documentation related to raw materials and consumables.
• Review change controls and assess potential quality and regulatory impact.
• Review vendor change notifications and determine potential impact to manufacturing processes in partnership with subject matter experts.
• Ensure compliance with cGMP requirements, internal procedures, and regulatory expectations.
• Provide quality oversight of raw material release activities supporting clinical and commercial manufacturing operations.
• Partner directly with vendors, suppliers, and internal stakeholders to facilitate timely release and disposition of materials based on manufacturing schedules and customer forecasts.
• Support supplier qualification activities, supplier quality investigations, and supplier performance monitoring initiatives.
• Provide QA support and oversight for deviations, investigations, CAPAs, and change controls initiated in or impacting the QA Raw Materials Department, Warehouse Operations, and incoming material processes.
• Participate in root cause investigations and support implementation of effective corrective and preventive actions.
• Ensure quality events are completed in accordance with site procedures and regulatory requirements.
• Collaborate with Supply Chain, Procurement, Warehouse Operations, Manufacturing, and Planning teams to ensure continuity of material supply while maintaining compliance.
• Provide quality oversight and risk assessments for material shortages, supplier performance concerns, inventory management activities, material planning decisions, and expedited material requests.
• Support business continuity efforts through proactive management of supplier and material-related quality risks.
• Maintain raw material retains, client cell bank inventories, and client drug substance retains.
• Manage inventory location assignments and tracking within applicable electronic systems.
• Support inventory reconciliation activities and ensure proper storage, traceability, and control of retained materials.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed