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 Scientist I in the Reference Laboratory. The Scientist I assures the Calibration Traceability by executing complex analytical testing of patient samples and other fluids to support the release process, stability testing, accuracy testing, and new method development. This testing uses a variety of instrumentation including, but not limited to, pH meter, manual spectrophotometers, Olympus AU400, Beckman AU480, flame photometers, atomic absorption, RIA, and HPLC. The Scientist I will maintain instrumentation, calibrates, runs quality control and analyzes requested samples. Position requires summary reports, analysis of technical data, evaluation of quality control, and instrument troubleshooting. Completion of Non-Conformance Records and/or Quality Investigations in a timely manner is required for this position. Work is scheduled, supervised, and follows established methods and procedures. Business decisions and product accuracy is dependent upon the technical ability of this individual and reproducibility of the analytical methods.

This position is located on-site in Rochester, New York.

The Responsibilities

• Completes product release tests by executing analytical testing on multiple types of equipment in compliance with all procedures; and provides analytical and manual dexterity to deliver accurate and precise results from complex analytical methods.

• Performs reagent, standard material, intermediates and final product testing. Monitors Reference Assay performance (Precision, Accuracy, Linearity) and is responsible for initially addressing or if needed, escalating reference testing issues and process concerns.

• Participates and/or assists in laboratory investigations, instrument and/or method validations/verifications; and completes non-conformance records timely.

• Completes analysis of data using spreadsheets or LIMS to report testing results. Reviews data for accuracy and completeness.

• Maintains equipment, reagents and supplies.

• Performs necessary housekeeping to ensure the laboratory is continuously maintained in safe, orderly and compliant condition

• With a working knowledge of quality control, monitor assay quality control performance and participates/leads quality control reviews for analytical tests.

• Works in PPE and Bloodborne pathogen training required

• Flexible in scheduling to ensure deadlines are met

• Physical requirements to lift up to 50 pounds of calibrators or reagents

• Limited work in freezer/refrigerator

• Must adhere to quality, GLP, GMP and regulatory compliance policies

• Completes other work-related duties as assigned.

The Individual

Required:

• Minimum BS degree in scientific or related field; equivalent combination of education and experience may be considered.

• 0 to 2 years of work experience in Biology, Microbiology, Quality, Regulatory.

• Strong mathematical skills.

• Strong problem-solving skills and attention to detail.

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

• 0-5% travel.

Preferred:

• Compliance in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical or Consumer)

• 1 or more years of lab experience.

The Key Working Relationships

Internal Partners: Management, Production Engineers, Production Operators, Maintenance Operators, Quality Engineers, Validation Engineers, Performance Assignment and Release, Accuracy Based Release Program Analysts, Research and Development Scientists and Project Leads, Product Support Scientists, Stability Analysts, Fluids Release Analysts, Microbiology Analysts, Customer Complaints and Customer Technical Services,

External Partners: Outside Vendors and Instrument Service Personnel

The Work Environment

The work environment characteristics are representative of an office, manufacturing, and laboratory environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is

$45,000.00 - 81,000.00 and is eligible for a bonus. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

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 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

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