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Job #03532

About our client Our Client is a biopharmaceutical based in Omaha NE. They focus on the development of vaccines and diagnostics products. They boast several products on the market, as well as a healthy pipeline of products in pre-clinical and clinical stages. This is an exciting opportunity for the right individual to join a fast paced environment! Position Location Quality Assurance Manager Nebraska Salary Highly competitive package, commensurate with experience Responsibilities 1) The Quality Assurance Officer is responsible for assuring compliance to current Good Manufacturing Practice. 2) Ensure that master documents are executed and personnel are trained before a project begins. 3) Supervise the approval or rejection of components, labeling, in-process material, and finished products. 4) Review production records and assure material meets specifications 5) Investigate and document errors which occur during production 6) Supervise material handling for approvals, releases, quarantines, and rejections. 7) Responsible for all non-conformances, failures, deviations, OOS, or unusual occurrences (CAPA event) that may arise in the course of manufacturing or distributing regulated articles. 8) Maintain an active, cross-functional approach to investigations, problem resolution, corrective and preventative actions in close collaboration with complaint handling, manufacturing, materials management, R&D. 9) Perform, direct and lead all duties associated with Quality Assurance including document change control, and lot file review. Requirements 1) Bachelor’s Degree in a Life or Physical Science or 5+ years of experience in the field. 2) Prior GMP experience is a must. 3) Strong communication skills for interaction with staff. 4) Prefer 1 year of supervisory experience. 5) Biologics or biotech experience a plus but not necessary.