Ortho Clinical Diagnostics

  • Quality Analyst 1

    Job Locations US-NY-Rochester
    Job ID
    Job Country
    United States
    Regulatory & Quality
  • The Company

    Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics.  Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.


    With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.


    Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.


    Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.


    Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.

    The Career Potential

    Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.

    Ortho is known in the industry as a leader in customer service and support.  Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do.  It’s who we are.  If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

    The Opportunity

    As the company continues to grow Ortho Clinical Diagnostics is recruiting for a Quality Analyst 1 located in our Operational Quality Laboratories in Rochester, NY. This position will be B shift (1:30pm -10:00pm). 


    Ortho Clinical Diagnostics serves the transfusion medicine community and laboratories around the world. We're a leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early, before they put lives at risk. Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life.


    The Responsibilities

    Working in a laboratory environment supporting the manufacturing operations, this person will be responsible for executing release testing and data analysis for release of product.   Individual will run, maintain, and troubleshoot Vitros 350, FS 5, 1, and 3400 analyzers.  This position works 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.  The individual will execute Vitros testing following Test Designs and analyze data for the release of product.  Routinely interacts with data management systems such as LIMS, SAP, Document Management Systems (OTIS), and Non-Conformance & CAPAs (QERTS). 



    The Individual


    • A BA/BS degree or equivalent is required.
    • A degree with a science concentration is preferred.
    • Previous laboratory or similar experience is required. 
    • Candidate must be willing to learn to run, maintain and troubleshoot Vitros 350, FS 5, 1, and 3400 analyzers. 
    • Candidate must have analytical knowledge required for production releases. 
    • Experience in OCD LIMS or SAP is preferred.
    • Careful attention to detail and accuracy of work are required.
    • 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. 
    • Experience in documentation protocols and procedures are a plus.
    • 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.
    • Having a working knowledge of computers and windows software is desired.
    • Full understanding of quality control is expected.
    • 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.
    •  This position requires working in a lab setting which includes standing for long periods of time and wearing personal protective equipment (PPE). 
    • Candidates are required to work in a BL2 Lab and handle human samples.
    • This position is located in Rochester, NY.
    • Work visa sponsorship is not available for this position

    Equal Opportunity

    Ortho Clinical Diagnostics 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. Ortho Clinical Diagnostics is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related 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 orthorecruiting@orthoclinicaldiagnostics.com.


    Supplemental Poster


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