QA Specialist - Raw Materials

KBI Biopharma, Inc.; Durham (NC); On-site; USD 85,000 - 105,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC is seeking a Specialist, Quality Assurance Raw Materials (QARM) to ensure quality and regulatory compliance for raw materials used in clinical and commercial manufacturing.

This role provides QA oversight in a cGMP environment and partners with suppliers to support timely material release and investigations. The Specialist collaborates with Manufacturing, Supply Chain, Quality Control, and external suppliers to maintain material quality, manage supplier

Qualifications

• Quality documentation review and quality impact assessments
• Raw material release and supplier quality oversight
• Quality systems support
• Supply chain and operational quality partnership
• Retain and inventory management

Responsibilities

• Quality documentation review and approval of specs, procedures, and change controls.
• Oversee raw material release and supplier qualification activities, ensuring timely disposition.
• Support deviations, investigations, CAPAs, and changes impacting QA RM and incoming material processes.
• Collaborate with Supply Chain, Procurement, and Manufacturing to maintain material supply and quality risk controls.
• Manage retention of raw materials, client cell bank inventories, and drug substance retains.

Job description

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.

Quality Documentation Review and Quality Impact Assessments

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.

Raw Material Release and Supplier Quality Oversight

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.

Quality Systems Support

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.

Supply Chain and Operational Quality Partnership

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.

Retain and Inventory Management

Retain 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.

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.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

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