The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role The Quality Release Specialist is responsible for the thorough review and release of all finished goods and raw materials. They compile, review, and release device history records (DHRs) to support the Athens manufacturing facility. Inspects raw material certificates of analysis and/or conformance for acceptance and usage. Responsible for all DHR, documentation filing and/ or scanning, on-site storage and coordinating with Quality for off-site long-term storage. The Quality Release Specialist will have the ability and familiarity with document management systems (QMS) for documentational updates, as needed. Compile and present release metrics (e.g. first pass acceptance, pass rates, defect rates, etc.) to leadership. Serve as point of contact for audit readiness of respective area. This role is located in Athens, Ohio. The Responsibilities Reviews Device History Records (DHR) and Incoming Inspection documents for accuracy, completeness and compliance with specifications as per applicable departmental procedure(s) for review of quality records. Executes the physical and electronic release (ERP) of finished goods and raw materials. Follows detailed procedures documented in SOP's, work instructions, forms and on check lists. Responsible for maintaining accurate records for all DHRs and Incoming Inspection documentation in adherence with Record Retention Policies. Responsible for all DHR, documentation filing and/ or scanning, on-site storage and coordinating with Quality for off-site long-term storage. Learn and execute Change Control (e.g. ECO) responsibilities for the implementation of revisions, corrections and changes to procedures and methods associated with the role. Ability to observe and participate in cross functional discussions, meeting and product reviews to learn about and support corrective actions for reoccurring problems as product release SME and quality representative. Complies associated metrics for presentation to leadership. Accountable to escalate any quality concerns or issues to management. Ability to summarize data and coordinate with manufacturing supervisors the efficient/ timely release of product. Ability to compile metrics data and identify trends as opportunities for improvement and ability to represent DHR Review during internal/ external audits. Serve as point of contact in site audits as SME work area. Assesses and implements DHR review and Incoming Inspection policies, standards, guidelines, technology and procedures. Perform other work-related duties as assigned. The Individual Required: Strong documentation, attention to detail (accuracy), organizational and communication skills Supports internal/external audit activities and process improvement initiatives. Highly skilled in typical computer systems and software, including proficiency in MS Office suite (e.g. Excel, Word, PowerPoint) and Adobe programs Preferred: Minimum of bachelor's or associate degree or 1-3 equivalent on-the-job working experience