Quality Assurance Specialist

Company Overview

Globyz Biopharma Services is seeking a Quality Assurance Specialist to manage Quality System and Quality Assurance functions at its Philadelphia, PA site.

Role Responsibilities

• Create, review, and approve Quality Management System documentation, including Deviation reports, CAPA, Customer Complaints, and Change Controls.
• Conduct GMP, GDP, and SOP training sessions for employees.
• Perform internal self-inspections to ensure compliance.
• Manage vendor qualification processes including audit questionnaire reviews and conducting on-site vendor audits.
• Prepare, review, and approve Quality Agreements with customers and vendors.
• Participate in or lead Customer Audits and Regulatory Inspections.
• Develop, review, and approve SOPs, Forms, and Specifications.
• Review secondary packaging and labeling batch records before and after execution.
• Assess facility qualification documents pre- and post-execution.
• Serve as a Subject Matter Expert and superuser during and after eQMS implementation.
• Report quality metrics regularly to management.
• Lead or participate in Quality Management Reviews.
• Engage in Risk Assessment and Mitigation activities.
• Collaborate with global QA departments to harmonize quality processes.
• Drive and implement process improvement projects.
• Provide quality assurance and regulatory assistance to other departments.
• Other duties as assigned.

Qualifications and Requirements

• Bachelor's degree or equivalent experience with at least 5 years in pharmaceutical quality assurance.
• Strong knowledge of GMP, GDP, and relevant regulatory frameworks with practical application skills.
• Proficient in Microsoft Office suite, including Outlook, Word, Excel, and PowerPoint.
• Ability to handle multiple tasks and adjust to shifting priorities.
• Results-driven, confident, self-directed, energetic, and motivated.
• Excellent analytical thinking and problem-solving capabilities.