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