Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Quality Assurance Department located in Fargo, ND and will be onsite working a first shift position. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Quality Assurance Team and report to the Operational Quality Assurance Supervisor. The Operational QA Specialist I activities include but not limited to; releasing manufacturing rooms for use, review to ensure Environmental Monitoring (EM) occurred, review of solution preparation, review of quality control documentation, and live documentation review of manufacturing processes and other quality department functions.
In this role, you will have the opportunity to:
Provide real-time support and oversight of manufacturing operations. Perform GDP review of manufacturing supporting documentation batch records and protocols at time of execution. Responsible for review of Good Documentation Practices (GDP) on executed documentation.
Releasing manufacturing rooms following required reviews and confirming acceptance criteria have been met. Oversee label generation to ensure traceability of final material.
Responsible for ensuring that solution preparation is performed in accordance with internal requirements and meets final specifications. Collaborate inter and intra-departmentally to resolve outstanding issues within required timeframes.
The essential requirements of the job include:
High School Diploma or equivalent GED required.
Demonstrated effective communication and interpersonal skills across all functions.
Ability to works independently or as a team player when cross-functional involvement is involved.
It would be a plus if you also possess previous experience in:
Quality related experience is preferred.
Bachelor of Science, preferred, life science related field preferred or equivalent experience.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
0 Quality Assurance Specialist jobs found in Fargo, ND area