QC Release Specialist 2

Responsible for developing, maintaining and coordinating compliant release processes for finished goods manufactured for Hull, ensuring adherence to Company Quality Systems, regulatory, statutory health & safety requirements, and Site Safety Policy. Acts as a subject matter expert in release controls and process of CMO, providing training and support to QC Release Personnel.

Responsibilities

• Apply high standards of occupational health & safety to comply with company policy and procedures.
• Perform all activities in compliance with relevant GMP, GDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and other applicable quality standards or regulations concerning medicinal products and medical devices.
• Ensure that all Quality Compliance Release external communications meet customer needs and facilitate improvement where necessary.
• Provide Quality Compliance Release support to CMO and Hull operations to ensure ...