Quality Assurance Specialist

Philadelphia, PA

About the role

The Quality Specialist is responsible for the management of Quality System and Quality Assurance functions at Globyz Pharma’s USA facility in Folcraft, PA.

Responsibilities

• Author, review, and approve Quality Management System documentation including: Deviation, CAPA, Customer Complaint, Change Control
• Provide GMP, GDP, and SOP training to employees
• Perform Self-Inspections
• Perform vendor qualification activities including review of audit questionnaires and performance of on-site audits
• Author, review, and approve Quality Agreements with Customers and Vendors
• Participate in and/or host Customer Audits and Regulatory Inspections
• Author, review, and approve SOPs, Forms, and Specifications
• Perform pre- and post-execution review of secondary packaging and labeling batch records
• Perform pre- and post-execution review of facility qualification documents
• Participate in eQMS implementation as QA Subject Matter Expert and serve as superuser post go-live
• Report quality metrics to management
• Participate in and/or lead Quality Management Reviews
• Participate in and/or lead Risk Assessment and Mitigation activities
• Liaise with all Globyz’s global QA Departments to harmonize processes
• Lead and implement process improvement projects
• Provide quality and regulatory support to other departments
• Other activities as required

Requirements

• Bachelor’s degree or equivalent experience
• Minimum of 5 years of experience in pharmaceutical quality assurance
• Solid understanding of GMP, GDP, and other applicable regulatory requirements and the ability to apply them to business scenarios
• Skilled in MS Office (Outlook, Word, Excel, PowerPoint)
• Ability to manage multiple responsibilities simultaneously and adapt to changing priorities
• Results-oriented, confident, self-motivated, and driven with high energy
• Good analytical abilities and problem-solving techniques