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Job Description
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
As the company continues to grow we are recruiting for a Quality Analyst I. This SPQC Quality Analyst I position is located in our Operational Quality Laboratories in Rochester, NY.This position will be B shift (2:00pm 10:30pm).Schedule Tuesday- Saturday.
This position is in Rochester, NY.
The Responsibilities
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Executing release testing and data analysis for release of product.
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Individual will run, maintain, and troubleshoot Vitros 350, FS 5, 1, and 4600 analyzers.
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Work in partnership with manufacturing Operations, Product Support and other technical support groups to ensure Quality and customer expectations are met prior to final release of the product.
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The individual will execute Vitros testing following Test Designs and analyze data for the release of product.
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Routinely interacts with data management systems such as LIMS, SAP, Document Management Systems (OTIS), and Non-Conformance & CAPAs (QERTS).
The Individual
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BA/BS degree or equivalent is required; A degree with a science concentration is preferred.
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Previous laboratory or similar experience is required.
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Candidate must be willing to learn to run, maintain and troubleshoot Vitros 350, FS 5, 1, and 4600 analyzers.
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Candidate must have analytical knowledge required for production releases.
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Experience in OCD LIMS or SAP is preferred.
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Careful attention to detail and accuracy of work are required.
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As an FDA regulated facility, documentation is key to this position in order to meet regulatory requirements; therefore, candidate must have an understanding of cGMPs and documentation in a regulated industry.
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Experience in documentation protocols and procedures are a plus.
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Candidate must have a demonstrated proven track record of planning and organization of daily workload, high affinity toward teamwork and demonstrated problem solving using innovative solutions.
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Having a working knowledge of computers and windows software is desired.
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Full understanding of quality control is expected.
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This position requires an individual who can multi-task, adapt to changes in daily workload and priorities, and function in a cross-functional team setting.
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This position requires working in a lab setting which includes standing for long periods of time and wearing personal protective equipment (PPE).
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Candidates are required to work in a BL2 Lab and handle human samples.
EOE/AA Disability/Veteran
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“At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career.
Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.”
