Provides Quality Assurance guidance, expertise, services, and QA oversight to ensure process, data and product quality. Leads and drives process and product improvements and provides quality-related services to Manufacturing and support groups for the Endeavor expansion project. Supports start-up activities as Quality representative. Develops, implements and evaluates tools and equipment for quality assurance and for product/process improvement. Performs a variety of quality duties to support expansion of Frederick manufacturing operations. Improves documentation, processes and applications to meet agreed-upon objectives. Participates actively in creation and approval of equipment and process SOPs, related documentation, and new product introduction. Supports and implements the transition of products and manufacturing processes from prototype to full production and through the entire life cycle of the product. In a process environment, interfaces with the process materials and adheres to safety guidelines. Partners with material management, quality peers, planning and procurement, manufacturing, and technical services to create and improve products and processes to meet expansion and production timelines, quality policies, and customer expectations. Utilizes digital solutions to optimize and maintain state-of-the-art manufacturing processes. May be required to use continuous improvement methodologies and understand quality regulations related to the life science industry. Reviews nonconformance documentation. Reviews Manufacturing executed documentation.
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Job Type
Full-time
Career Level
Mid Level