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

At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Scientist I supporting assay R&D in Rochester, NY. The Scientist I will work collaboratively within a team environment to support all phases of Assay Development activities. This role is responsible for performing laboratory assignments related to experimental design, execution, and evaluation of assay performance on VITROS and other QuidelOrtho diagnostic platforms in compliance with current Good Manufacturing Practices (cGMP) and established Quality System requirements. Responsibilities include test execution, documentation, analysis, and

summarization of experimental data, as well as preparation of complex biological solutions using established laboratory procedures and protocols.

Additional laboratory responsibilities may include preparation and reconstitution of calibrators and controls; weighing chemicals; performing volumetric additions of biological components; pipetting; filtration and ultrafiltration procedures; and other standard laboratory techniques.

This position is onsite full-time in Rochester, NY.

The Responsibilities

• Collaborate as part of a technical team to create, execute, and interpret experimental test designs for VITROS analyzers in support of verification and validation activities for new in vitro diagnostic products and processes, following established protocols and Standard Operating Procedures (SOPs).
• Execute assay performance testing on diagnostic instrumentation to support accurate, reliable, and reproducible test results.
• Perform routine analyzer maintenance, including daily, weekly, and monthly maintenance activities, as well as calibration, quality control (QC), troubleshooting, and documentation in accordance with SOPs.
• Maintain accurate, complete, and compliant records of all work performed in alignment with cGMP requirements and Quality System procedures, including Design History Files, QC documentation, equipment maintenance records, and associated laboratory documentation.
• Maintain a clean, organized, and safe laboratory environment, including proper cleaning and maintenance of workspaces and instrumentation following testing activities.
• Complete required training and support training activities related to SOPs, protocols, laboratory procedures, and other controlled documents.
• Support additional laboratory and project-related activities as assigned.
• Overtime may be required based on business and project needs.

The Individual

Required:

• Bachelor's degree in Chemistry, Biology, Biochemistry, Biotechnology, Medical Technology, Clinical Laboratory Science, or a related scientific discipline.
• Minimum of 1 year of relevant laboratory experience or an equivalent combination of education and experience.
• Basic understanding of laboratory techniques, scientific methodology, and data analysis.
• Ability to perform general biochemical laboratory procedures, including the preparation and handling of reagents, controls, calibrators, and human or animal blood and blood products, human urine, human CSF.
• Knowledge of safe laboratory practices, including chemical and biological material handling.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Strong written and verbal communication skills with the ability to accurately document, summarize, and communicate scientific results.
• Ability to maintain complete and accurate documentation in accordance with quality system requirements and laboratory procedures.
• Demonstrated ability to work effectively both independently and within a collaborative team environment.
• Strong organizational skills with attention to detail and a commitment to producing high-quality work.
• Ability to prioritize multiple assignments and meet project deadlines.
• Sound judgment and problem-solving skills appropriate for an entry-level scientific role.
• Commitment to maintaining a safe, compliant, and productive laboratory environment.
• Less than 10% domestic and/or international travel may be required.
• This position is not currently eligible for visa sponsorship.

Preferred:

• Experience in experimental design, analytical testing, data analysis, and interpretation
• Familiarity with laboratory instrumentation and diagnostic testing methodologies
• Experience with statistical software packages such as Minitab or equivalent data analysis tools

The Key Working Relationships

Internal Partners:

• Quality/Regulatory
• Assay and Systems R&D
• Operations
• Manufacturing
• Service
• Project Management Office.

External Partners:

• Development and Manufacturing partners.
• May interact with outside vendors for arrangement of service or calibration of test equipment or procurement of raw materials or test specimens.

How We Work

At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they’re essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together – Collaborate intentionally, grow as a team
• Make It Happen – Focus on priorities, embrace continuous improvement
• Commit to Service – Cultivate a service mindset
• Embrace Inclusion – Be open and authentic, welcome diverse perspectives

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse 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

Working Conditions

• Noise level: Laboratory sounds or a pitch that may cause distraction.
• Temperature: May have to perform testing in an environmental chamber (extreme heat, cold, and/or humidity) or work in walk-in refrigerators or freezers.
• Working around moving machinery
• Protective equipment required: gloves, lab coat, eyewear
• Exposures: Biological/biohazardous materials (including but not limited to human or animal blood and blood products, human urine, human CSF), chemical fumes, toxic chemicals, airborne particles, odors, or other unpleasant surroundings
• Other factors: Possible overtime

Physical Demands

Computer work, repetitive movements of hand(s), sitting, standing, walking, carrying, reaching.

Other physical demands include:

• Bending
• Crawling
• Stooping
• Vision
• Climbing or balancing
• Kneeling
• Crouching
• Talking or hearing
• Tasting or smelling
• Close Visual Acuity (visual Inspection for small defects or parts, extensive reading or analyzing data.)
• Intermediate Visual Acuity (operating machines, computer terminal or work at or within arm’s reach).

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 $28/hour to $32/hour and is bonus eligible. 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 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 recruiting@quidelortho.com.

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