Associate Specialist, Quality Systems

The Associate Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

Responsibilities:

• Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
• Conduct initial regulatory review of documents.
• Assist with audits of documentation, facilities and equipment.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Support project teams in planning, preparation, review and approval of quality documentation.
• Collect and compile key quality metric data.
• Perform QA review for product release.
• Participate in training and education programs for various aspects of quality assurance.