QA Specialist

Responsibilities:

• Lead the creation and review of supplier evaluation documents, including evaluations, questionnaires, and audit reports.
• Oversee the creation and review of Supplier Corrective Action Requests (SCARs), ensuring follow-through to resolution.
• Develop and review quality agreements between suppliers and INCOG.
• Review material specifications for compliance and accuracy.
• Plan and monitor internal audit activities and track corrective actions.
• Assist with external/third-party audits.
• Support recall and complaint management processes.
• Contribute to Annual Product Review activities.
• Generate and review regulatory surveillance reports using the Redica platform.
• Manage multiple projects simultaneously in a fast-paced environment.
• Provide support during business hours (8 AM – 5 PM, Monday-Friday) and as needed outside of regular hours.

Required Qualifications:

• Bachelor’s Degree required, preferably in a related scientific field (e.g., Chemistry, Biology, Biochemistry, Microbiology).
• A minimum of 5 years of experience in the biopharma industry, with increasing responsibilities in supplier quality management or supply chain quality.
• At least 5 years of experience in conducting internal audits.
• A minimum of 2 years of experience with recalls, complaints, and Annual Product Review activities in the biopharma industry.