QUALITY ASSURANCE MANAGER is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a QUALITY ASSURANCE MANAGER identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, QUALITY ASSURANCE MANAGER typically requires a bachelor's degree. Typically reports to a director. The QUALITY ASSURANCE MANAGER manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a QUALITY ASSURANCE MANAGER typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
COMPANY MISSION
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
POSITION SUMMARY
The Senior Manager of Quality Assurance (QA) is accountable for overseeing the GMP cloning operations to be conducted in the eGenesis facility located in Middleton, WI. This will include supporting the manufacturing operations, facilities/utilities/systems/equipment lifecycle, and supporting all the records generated as part of the operations to maintain the facility in a state of compliance. This candidate will also be responsible for providing quality guidance to the activities being performed at the eGenesis facility located in Rensselaer, IN. This position reports to the Vice President of Quality and is a high visible and impactful position that will require cross-functional interaction across the multiple teams in the Organization. This position will be located in Middleton, WI.
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