Associate Specialist, Quality Assurance
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About The Position
The Shop Floor Quality Assurance Associate is a pivotal role within the Vaccine Manufacturing Facility in Durham, responsible for ensuring that all quality-related functions are executed effectively to support the manufacturing of TICE® BCG, a critical medicine for bladder cancer treatment. This position is integral to maintaining compliance with Good Manufacturing Practices (GMP) and regulatory standards, ensuring that the facility operates at the highest quality levels. The Associate will actively participate in a team-oriented culture, contributing to a collaborative environment that emphasizes quality and compliance in all manufacturing processes. In this role, the Associate will conduct periodic shop floor audits, provide direct in-line quality support, and oversee environmental monitoring matters. They will be responsible for reviewing atypical events, assessing their impact on product quality, and providing oversight during alarm events that occur during processing. The Associate will also review and approve batch record documentation and manage any incursions that may arise, ensuring that all actions taken are in line with regulatory requirements and internal policies. The new manufacturing facility represents a significant investment in expanding production capacity, which is essential to meet the growing global demand for TICE BCG. The facility encompasses comprehensive processing capabilities, including drug substance and product processing, biotech culture growth, and quality control laboratories. The Associate will play a crucial role in supporting these operations, ensuring that all quality assurance activities are performed systematically and rigorously, thereby safeguarding product integrity and compliance with industry standards.
