Quality Assurance Specialist
Boothwyn, PA

Position Description

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

As a Member of our Quality Team you’ll be expected to:

• 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, 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 and 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

Applying for the Job

Interested and qualified individuals can apply to info@globyz.com

To apply you must meet these 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