What are the responsibilities and job description for the Quality Assurance Specialist position at Globyz Biopharma Services?
- USA
- Philadelphia, PA
- Posted 2 years ago
Position Description
The Quality Specialist is responsible for the management of Quality System and Quality Assurance functions at Globyz Pharma’s, USA facility at Folcraft, 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
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