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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 one QuidelOrtho, we are seeking a Scientist II to work in our Fluids Manufacturing facility. This Scientist II will be responsible for working both independently and as a team member to conduct root-cause investigations of field and/or factory production failures, evaluates residual risk and makes recommendations for product disposition. Assists in the identification, validation and implementation of corrective actions. The individual will define product performance testing and develop test designs, and potentially execute testing in the laboratory as well, to evaluate critical to quality product characteristics in a timely manner to maintain the continuity of supply, support product/process investigations and material obsolescence. This position may lead or assist projects that improve product performance, increase operational efficiency and enhance customer satisfaction. The Scientist II will provide data driven recommendations and input to product risk assessments as part of validation and nonconformance evaluations.

This position is located in Rochester, NY.

The Responsibilities

• Responsible for working both independently and as a team member to conduct root-cause investigations of factory production failures and/or product atypical results. Evaluates residual risk and makes recommendations for product disposition decisions and corrective actions.
• Accountable for clear and accurate documentation of conclusions within QuidelOrtho's quality system with supporting rationale, which may include summarizing results and presenting for review at Materials Review Board (MRB) in a small team format.
• The individual will define product performance testing and develop test designs to evaluate critical to quality product characteristics in a timely manner to maintain the continuity of supply, support product/process investigations, material obsolescence projects and corrective actions or product improvements. This also includes managing and documenting changes as necessary in QuidelOrtho's quality system.
• The individual will review and analyze data to draw conclusions and make recommendations for product disposition and to evaluate product changes when applicable.
• This role will lead project qualifications and validations of a moderate complexity, with guidance. Prepare reports, including protocols, testing analysis, and summary reports.
• Maintain working knowledge of cGMP requirements to ensure adherence to compliance policies and regulations.
• Understand and wear the appropriate PPE when working in the laboratory and manufacturing environments.
• Assist in internal and external audit preparation and participation, as needed.
• Accountable for adhering to all quality, regulatory and safety guidelines.

The Requirements

Required:

• Minimum BS degree in scientific field.
• Demonstrated experience conducting root cause investigations and familiarity with Process Excellence tools or equivalent methodologies.
• Ability to work in a manufacturing environment, resolve urgent product issues in a timely manner and flexibility to adjust to changing priorities.

Preferred:

• Degree in Chemistry, Biology or Engineering field.
• Familiarity with VITROS MicroSlide/MicroTip products and with VITROS analyzers.
• Experience in writing technical documents and proficiency with Minitab (or equivalent) statistical software.

The Key Working Relationships

Internal Partners: Management, Production Engineers, and Quality Engineers

External Partners: Material Suppliers

The Work Environment

The work environment characteristics are representative of a laboratory roughly 75-85% of the time and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. 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 $58,000 to $94,000 and is bonus eligible or eligible for incentive compensation. 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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