Quality Assurance Specialist

Are you looking to make a difference in a patient's life?  At AmerisourceBergen, you will find an innovative culture that is patient focused and dedicated to making a difference.  As an organization, we are united in our responsibility to create healthier futures.

What you will be doing...

The Quality Assurance Specialist is primarily responsible for the supplier approval process and day-to-day engagement with suppliers to ensure compliance with company policies, regulatory requirements, and supplier agreements.  

• Create, review, and ensure completion of Quality/Pharmacovigilance Agreements with suppliers.  Maintain all Quality and Technical Agreements pertaining to suppliers within the Quality Management System.
• Perform audits of suppliers to ensure practices are aligned with regulatory and other requirements which includes onsite audits and desktop assessments. Based on these audits, exercise specific judgement of a potential supplier’s fitness to supply goods and services to ABC. 
• Create audit reports, assist suppliers with creation of CAPA, and ensure observations/CAPA are corrected as intended and on schedule in conjunction with ABC policy and regulatory requirements applicable to the good/service provided.
• Serve as a primary contact/liaison with the suppliers on behalf of Quality Assurance for all items related to supplier complaints and closure of open issues.
• Work jointly with Quality, Procurement, Supplier Trade Relations, and other teams as needed to ensure all groups are informed on the status of new suppliers. 
• Coordinate completion of requirements for new and existing suppliers.
• Create and revise the Approved Supplier List as needed.
• Interact with AmerisourceBergen Corporate to coordinate the supplier addition process whenever an existing ABC supplier is added to the Approved Supplier List.
• Lead the site’s Internal Audit Team – regular meetings, training of new auditors, and manage annual audit schedule.
• Partner with the Accounting Team to ensure new suppliers are added to Master Data and the ERP system as required and ensures suppliers are removed from the same systems when needed.
• Prepare various reports and metrics for the Procurement and Quality teams to track the ongoing status of suppliers. 
• Ensure all supplier files are maintained and archived in accordance with established documentation policies and procedures.
• Ability to travel up to 25%
• Perform related duties as assigned.