Quality Assurance Specialist

Responsibilities:

• Generate and review supplier evaluation documentation, including evaluations, questionnaires, and audit reports.
• Manage and track Supplier Corrective Action Request (SCAR) processes to ensure effective resolution.
• Draft and review quality agreements between suppliers.
• Review and evaluate material specifications.
• Lead internal audit planning and track mitigation actions.
• Support and assist with external and third-party audits.
• Assist with recall and complaint management processes.
• Contribute to Annual Product Review activities.
• Oversee multiple projects simultaneously in a fast-paced environment.

Qualifications:

• Bachelor’s Degree in a related field (e.g., Chemistry, Biology, Biochemistry, Microbiology).
• Minimum of 5 years of pharmaceutical industry experience with increasing responsibilities in supplier quality management or supply chain quality.
• At least 5 years of experience in internal audit activities.
• Minimum of 2 years of experience in biopharma activities related to recalls, complaints, and Annual Product Reviews.
• Strong written and verbal communication skills.
• Proficiency with computer systems, including SAP and reporting/data analysis software (e.g., Word, Excel, Visio, JMP, Minitab).