QA Specialist - Raw 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.

Qualifications

• Bachelor's degree in a relevant field such as Chemistry, Biology, Pharmaceutical Sciences, or a related discipline.
• Minimum of 5 years of experience in quality assurance, preferably in a regulated environment like pharmaceuticals.
• Experience with cGMP regulations and knowledge of Good Manufacturing Practices (GMP).
• Strong understanding of raw materials and consumables in biopharmaceutical manufacturing.
• Excellent communication and collaboration skills, including ability to work effectively with cross-functional teams.
• Proficiency in Microsoft Office Suite, particularly Excel for data analysis and project management.
• Ability to manage multiple tasks and priorities simultaneously.

Skills

• Quality assurance and compliance expertise.
• Supplier relationship management.
• Inventory management and supply chain coordination.
• Root cause analysis and problem-solving skills.
• Effective written and verbal communication skills.
• Project management and organizational skills.

Benefits

• Competitive salary commensurate with experience.
• Health insurance coverage.
• Paid time off and vacation days.
• Professional development opportunities.
• Flexible work schedule.
• Employee assistance program.

Pay

Salary range: $70,000 - $90,000 annually.

Schedule

Full-time position with standard Monday through Friday workweek.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce.