Quality Assurance Specialist II Category: Quality Assurance Description: Quidel Corporation is a leading manufacturer of diagnostic healthcare solutions serving to enhance the health and well being of people around the globe with well known and respected products that provide healthcare professionals with accurate and cost-effective diagnostic information at the point of care (POC). Our core competencies and capabilities focus on immunoassay and molecular testing in the areas of: infectious disease, cardiology, womens health, and virology. Under the supervision of the Supervisor/Manager, the scope of this position is responsible for carrying out the daily operations of the Batch Record Department as defined by the Quidel Quality Management System and within defined company policies, procedures and regulatory requirements. Essential Functions: * Responsible for managing throughput of all QA reviewed Device History Records, and others as assigned * Responsible for reporting of monthly trending metrics, and developing weekly priorities * Work with groups within the organization to get corrections and clarifications to Device History Records * Generate Certificate of Conformance, Certificates of Analysis for Final Product and associated chemistries and review and approve specialized Certificate of Conformance / Certificates of Analysis as required * Prepare labeling for all products that are reviewed * Frequently interacts with peers and various management levels across departments to ensure quality compliance. Interaction normally requires the ability to gain cooperation of others which may include: Internal Customers, External Customers, and Quality Team and other Department Personnel Requirements: Education and Experience: * Requires a Bachelors Degree (BS/BA) in Science or equivalent combination education and/or work experience required. * One to three years of progressive responsibilities and experience in Quality Systems and/or Quality Control in Pharmaceuticals, Medical Devices and/or IVD manufacturing environment preferred. Knowledge/Skills: * Must have a working knowledge of FDA Quality System Regulation, ISO Standards and other regulatory agencies * Must be highly skilled in typical computer systems and software and must be proficient with standard office equipment (including, but not limited to MS Office and Adobe programs/applications) * Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities Before you apply, please make sure you share Quidels values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer driven, focused on execution, and new product oriented. We succeed by being determined, optimistic team players. Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Location San Diego, CA USA Minimum Experience (yrs): 1-3+ Required Education: Bachelors of Arts / Science