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