Job Description
We are seeking an experienced Clinical Supplies Quality Assurance Specialist to join our team. This position plays a critical role in ensuring the integrity of our global clinical supply chain by conducting disposition activities for sourced drug product.
In this role, you will be responsible for evaluating and disposing of clinical supply materials, ensuring they meet all applicable policies and procedures and governing regulations. You will also serve as the point of contact for Sourced Drug Product releases and Shelf-Life Extensions, both ongoing projects and new initiatives.
Additional responsibilities include providing support and coordination for quality control laboratory activities related to Sourced Drug Product testing, coordinating and supporting the preparation of procedures, processes and quality improvements, and assisting in the coordination of significant quality events including fact-finding, investigation, coordination of clinical quarantine and recovery actions.
To succeed in this role, you will require excellent analytical and problem-solving skills, along with experience in pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field. You should have a strong understanding of current Good Manufacturing Practices (cGMPs) and regulatory requirements as they apply to the pharmaceutical field or a related area.
This is an exciting opportunity to work with a dynamic team and contribute to the development and delivery of high-quality products that make a meaningful difference in people's lives.