Scientist I (Assay Development)

Quidel • Rochester, NY • 6h ago

The OpportunityQuidelOrtho 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 RoleQuidelOrtho is looking to hire The Scientist 1 will work in a team environment on all phases in support of Life Cycle Management Verifications and Validations or testing in support of System Development . The Scientist will perform various assignments related to the experimental design and testing of assay performance on the VITROS and other QuidelOrtho products in the laboratory in accordance with cGMP regulations. Preferred candidate has a minimum of 6 months experience running VITROS analyzers. This position will also include documentation and summarization of the experimental data. Additional laboratory work may include preparation of complex biological solutions using established protocols, including reconstitution of calibrators and controls. These protocols may include weighing chemicals, volumetric additions of various biological components, pipetting, filtration, ultra-filtration, etc.This position will be located onsite in Rochester, NY location.The Responsibilities- As part of a technical team, create, execute, and understand experimental test designs for the VITROS analyzers to complete testing aimed for the verification and validation of new vitro diagnostic products or processes using established protocols and SOP's.- Provide technical support by executing test designs on diagnostic instruments to drive accurate test results.- Maintain analyzer equipment related to the VITROS testing (daily, weekly, and monthly maintenance) and perform necessary calibration, QC, and documentation according to SOPs.- Maintain accurate records of work performed in accordance with cGMP and the procedures outlined in the Quality System. This includes Design History files, QC, equipment maintenance, and other associated testing documentation.- Maintain a neat, orderly, and safe workplace and clean work area and analyzer upon test completion.- Perform training on SOP's, protocols, and other laboratory documents- Perform other work-related duties as assigned.The IndividualRequired:- BS in Clinical Laboratory Science / Medical Technology, Chemistry, Biology or related field or equivalent combination of education and experience.- A minimum of 1 year experience in a lab environment is required. Basic understanding of laboratory skills and techniques (weighing, pipette use, volumetric measure, etc.) are required.- Familiarity with safe chemical and biological handling required.- Basic computer skills (MS Word, MS Excel) are required.- Strong attention to detail.- Ability to work collaboratively or independently.- Excellent verbal and written communication skills will be required.- Travel 5% or less.- This position is not currently eligible for visa sponsorship.Preferred:- Ability to do some level of troubleshooting- Ability to perform primary testing on VITROS analyzers- Ability to present information cross functionallyThe Key Working RelationshipsInternal Partners:- Internal partners: RND, Quality, Regulatory, PMO, MarketingExternal Partners:- External partners: Customer sites, vendor interactionThe Work EnvironmentThe work environment characteristics are representativ

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