Quality Analyst 1

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 we continue to grow as QuidelOrtho, we are seeking a Quality Analyst I who is responsible for using data to determine reliability and conformance of quality control process. They will be accountable for identifying trends and reoccurring issues and suggesting solutions. This Quality Analyst 1 position is located in our Operational Quality Laboratories in Rochester, NY. We are hiring 2 individuals for our B shift (2:00PM to 10:30PM). Schedules are Tuesday - Saturday OR Sunday - Thursday.

The Responsibilities

• Executing release testing and data analysis for release of product.
• Individual will run, maintain, and troubleshoot Vitros 350, FS 5, 1, and 4600 analyzers.
• 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.
• 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).
• Performs other work related duties as assigned.

The Individual

Required:

• BA/BS degree or equivalent.
• Previous laboratory or similar experience.
• Candidate must be willing to learn to run, maintain, and troubleshoot Vitros 350, FS 5, 1, and 4600 analyzers.
• Candidate must have analytical knowledge required for production releases.
• Careful attention to detail and accuracy of work.
• 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.
• 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.
• Full understanding of quality control.
• 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.
• Candidate must be able to work B shift: 2:00 pm - 10:30 pm on either a Tuesday - Saturday or Thursday - Sunday schedule.

Preferred:

• A degree with a science concentration.
• Experience in OCD LIMS or SAP.
• Experience in documentation protocols and procedures.
• Having a working knowledge of computers and windows software.

The Key Working Relationships:

Internal Partners: Operations, Product Support, and Quality Control

The Work Environment:

The work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues, and samples. Position requires ability to lift to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.

Equal Employment Opportunity

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 the 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

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