Quality Specialist I - Product Release in San Diego California United States

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Summary of Duties and Responsibilities Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments. Our more than 6,000 associates worldwide are driven towards breakthrough achievements in research, product development and the worldwide distribution of healthcare solutions. We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. There has never been a more exciting time in our company’s history. Visit our website to learn more about the many career opportunities we have available today. The Quality Specialist I (Product Release) whowillcontinue to maintain the turn-around-time and compliance expectation for document review and product release due dates. DESCRIPTION OF POSITION RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Perform intermediates and final product release activities, including batch record and final data review. Approve quality records (batch records, certificate of analysis/conformance, amendments). Interact with multiple departments to ensure quality record issues are addressed in a comprehensive and timely manner. Perform product release activities in electronic systems. Performs initial troubleshooting activities related to product release activities. Perform other responsibilities as assigned. Qualifications Demonstrate knowledge of federal and other regulations, e.g. QSRs, ISO, ISO 13485. Understands and is aware of the quality consequences which may occur from the improper performance of their specific job and has an awareness of device defects that may occur in their area of responsibility. Must have strong computer skills with experience working in Oracle a plus. Education Typically requires High school and 4-6 years related experience, AA and 2-4 year related experience, BS and 0-2 years related experience. Experience Specialized Knowledge Additional Details Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer.
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Quality Control

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