Product Support Scientist 2

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 6000 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 Opportunity

The Product Support Scientist 2 participates in the planning design and execution of activities for product validation root cause investigation of product failures and non-conformance investigations as assigned. The Scientist 2 must be well versed in standard principles theories concepts and techniques in the execution of clinical laboratory testing. The Scientist 2 must exercise good judgment within defined company practices and policies to obtain solutions to problems of a moderate technical scope and complexity for QuidelOrthos Transfusion Medicine products and associated manufacturing/production.

The Responsibilities

• Lead or provide support to Project Managers for conducting product validation activities. Prepare basic validation protocols and summary reports. Present findings to the project team. Complete activities within a defined project schedule and timeline.

• Under general supervision plan design and perform diagnostic assay activities to support Root Cause Investigations of product failure non-conformances and customer complaints. Provide documented evidence of technical findings and quantitative analysis.

• Suggest improvement to methodologies processes products and systems as an outcome of projects and investigations. Implement improvements when needed.

• Support Site Quality Initiatives. Participate in Quality audits as a representative for Product Support. Complete requests in the Quality Management System as assigned.

• Maintain the Product Support Laboratory reagents and equipment including automated analyzers. When assigned perform equipment calibrations and PMs.

• Initiate Change Requests Change Notices and associated documentation for validations product changes and process changed.

• Perform other work-related duties as assigned.

The Individual

Required

• Minimum of a Bachelors Degree in Science or related field.

• Educational focus in Medical Technology or Clinical Laboratory Medicine.

• Minimum 3 years experience in the clinical laboratory environment or 2 years in Transfusion Medicine (Blood Banking). Other relevant job experience will be considered in lieu of clinical healthcare setting.

• Experience in cGMP processes associated with reagent/biologic materials and products.

• Excellent written/verbal communication skills.

• Experience with Microsoft Word Excel and PowerPoint is essential to this position.

Preferred

• Certified Medical Technologist; MT(ASCP) or equivalent clinical laboratory scientist.

• Experience working with CBER (FDA) regulated licensed biologics.

Key Working Relationships

Internal This position must maintain a strong working relationship with the Quality Control Lab Quality Engineers Quality Assurance Regulatory Affairs Formulations Manufacturing/Production Materials Management Ops Engineering Facilities and EHS.

Work Environment

The Scientist 2 role requires working in both the laboratory and office environments. This position will have exposure to biological hazards including human blood products.

The Physical Demands

Required to wear personal protective equipment when necessary; including but not limited to: gloves eyewear safety glasses lab coat face mask. Requires close visual acuity for inspection of small parts extensive reading analyzing data and use of a microscope. Repetitive movement of the hands; including typing pipetting manual writing/documenting.

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 $68000 to $92000 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 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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