Scientist III

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 3. The Scientist 3 is a full-time position in Clinical Chemistry Operations Product Support and will be responsible for working both independently and as a team member to evaluate and make recommendations for specific product dispositions and obsolescence projects for supply continuity, and support validation activities (raw material/supplier changes, process improvements, supplier-initiated validations). This role will primarily support the products in Fluids Manufacturing. 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 field and/or factory production failures, evaluates residual risk and makes recommendations for product disposition and/or corrective actions.
• Accountable for clear and accurate documentation of conclusions within Ortho'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 authoring validation plans and reports, managing and documenting changes as necessary in Ortho'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 including preparing reports, writing and designing test 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 (including BL2 laboratory)
• This role may also involve some laboratory / pilot scale experimentation as necessary.
• Assist in internal and external audit preparation and participation, as needed.
• Accountable for adhering to all quality, regulatory and safety guidelines.

The Individual

• Bachelor's Degree in Medical Technology, Science, or Engineering fields. Additional degrees
• Minimum 7 years' experience associated within laboratory within a FDA regulated industry.
• Familiarity with VITROS products and VITROS analyzers is highly desired.
• Demonstrated experience conducting root cause investigations and familiarity with Process Excellence tools or equivalent methodologies is also preferred.
• Experience in change control documentation systems (Windchill) a plus.
• Strong written and verbal communication skills with attention to detail are required.
• Familiarity with biological formulations and processing techniques very highly desired.
• Individual wlll have effective communication skills and ability to present data in small group settings.
• Ability to demonstrate flexibility and adaptability.
• Organization skills are important to work on several projects in parallel.
• Travel is not expected, less than 5%.

The Key Working Relationships

Internal Partners:

Management, Production Engineers, and Quality Engineers

External partners:

Raw Material Suppliers

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 $71,000.00 - $128,000.00 annually. 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 [email protected]

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