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Under the direction of the Vice President of Operations, the QA Associate will be responsible for QA activities in our Manufacturing facility. GBS offers an exciting opportunity to assist with the development and commercialization innovative new IVD products to the Medical device market. Essential Duties and Responsibilities: Develop, implement and maintain the quality assurance programs, policies and processes to ensure quality. Work collaboratively with Regulatory and Document Control. Develop and maintain quality systems to establish standards relating to activities and products. Develop and maintain quality systems to measure performance against established standards. Communicate quality issues across all departments and train staff as needed. Help establish QA department databases to track manage and control manufacturing documents. Assign lot numbers, material part numbers, and various other document tracking numbers. Manage and perform RM activities that lead to release of purchased material for manufacturing use. Maintain completed records for manufacturing WIP and finished goods. Perform final quality review and approve release of finished goods to be shipped. Work with Technical Service (as needed)on device investigations or regulatory activities. Know and effectively follow SOPs, policies, and cGMPs. Coordinate equipment calibration activities.
Relocation costs may be covered.
Quality Assurance related experience in a cGMP environment is a plus. Strong communication, prioritization, writing and organizational skills. Work on quality assignments in collaboration with various department system owners. Analytical problem solving ability. Strong team player interpersonal skills and ability to work with others in a positive and collaborative manner. Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities. Ability to utilize multiple word-processing and database applications including MS Office suite, such as Word, Excel, and Project, as well as Adobe Acrobat and Sharepoint
Email cover letter and resume' only please.