QA Associate

About the role

Almac Group is currently seeking a Quality Assurance Associate for our Durham, NC location. The Quality Assurance Associate is primarily concerned with the review of packaging and labeling batch records and the release of clinical supplies. The Quality Assurance Associate assures that no product is released until its quality has been deemed satisfactory having been manufactured, processed, packed, and held in accordance with Almac Clinical Services Standard Operating Procedures, current Good Manufacturing Practices, and customer specifications.

Responsibilities

• Review and approve documentation from any site associated with packaging and labeling of clinical supplies, including but not limited to:
  • Packaging Specifications
  • Packaging and Labeling methods and design layout
  • Executed packaging and labeling records
  • Medication number lists
• Release of clinical supplies upon successful review.
• Distribution instructions shipping clinical supplies
• Labeling Instructions for Depots
• Release of clinical supplies upon successful review and activation of specific countries to allow shipping activities to commence.
• Assist quality management with the following tasks as needed:
  • Report/escalate serious/potentially serious breaches of GMP compliance or matters of concern to QA Team Leader in an open and timely manner for appropriate resolution.
  • Prov