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.

As we continue to grow as QuidelOrtho, we are seeking a Quality Lab Analyst to work in our MicroWell Release Lab supporting QA for the Microwell product line in our new manufacturing facility in Rochester. Will execute complex analytical tests and perform data analysis of VITROS products (Chemistry Calibrators, Controls, Reagents, and other support fluids) using the MicroWell release software tool, Excel spread sheets, and a variety of instrumentation (VITROS 3600, 5600 and Eci Chemistry Systems).

Will lead junior laboratory staff by scheduling lab testing to support the production schedule, and will assist in laboratory investigations, ensuring product performance specifications. This position is in Rochester, NY.

• Complete release and in process tests supporting Vitros products by executing analytical testing on multiple types of equipment in compliance with all procedures; and provide analytical and manual dexterity to deliver accurate and precise results.

• Perform complex quality data analysis on all types of release tests. This includes the use of validated spreadsheets and the laboratory data analysis software. Create Quality records for test failures and escalates to management.

• Maintain Quality documents when product specifications change due to new lots of internal test fluids or a result of a Non-Conformance investigation.

• Perform reagent, calibrator, performance verifier, fluid intermediates and final product testing. Organize and ensure completion of Release Laboratory testing within established standard operating procedures and frequently assist team members to accomplish product release tests to meet production timelines.

• Participate and/or lead Release Laboratory investigations. The individual will contribute to the documentation of any quality records resulting from investigations or product releases.

• Review data of internal controls and other release fluid crossover tests for accuracy and completeness and serve to provide the peer review of other staff member's data.

• Maintain lab supply inventory for testing of VITROS Products and manages equipment maintenance/calibration records schedule.

• Participate in Laboratory Validations of new assays and is responsible for the assay configuration in the laboratory data analysis software.

• Perform other work-related duties as assigned.

• Bachelor's degree in scientific or related field with a minimum of 2 years of work experience in Biology, Chemistry or Medical Technology in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical). Equivalent combination of education and experience may be considered.

• Strong problem-solving skills.

• Strong attention to detail.

• Strong written and verbal communication skills.

• Ability to work independently and as part of a team.

• Ability to work overtime and occasional weekends or alternate shifts as needed.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at

#LI-SP1