Product Support Scientist II

The Opportunity

Quidel Ortho 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.

As we continue to grow as one Quidel Ortho we are seeking a Product Support Scientist II to work in our manufacturing facility in Pompano Beach Florida. The Product Support Scientist II participates in the planning, design, and execution of activities for product validations, root cause investigations of product failures, and non-conformance investigations. The Scientist II must be well versed in standard principles, theories, concepts and techniques in the execution of clinical laboratory testing.

The Scientist II must exercise good judgment, within defined company practices and policies, to obtain solutions to problems of a moderate technical scope and complexity for Quidel Ortho' s Transfusion Medicine products and associated manufacturing/production.

This position is in Pompano Beach, Florida.

• 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 changes.

• Perform other work-related duties as assigned.

Required:

• Minimum of a Bachelor's Degree in Science or related field.

• Educational focus in Medical Technology or Clinical Laboratory Medicine.

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

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

Internal Partners:
Quality Control Lab, Quality Engineers, Quality Assurance, Regulatory Affairs, Formulations, Manufacturing/Production, Materials Management, Ops Engineering, Facilities, EHS

External Partners:
As assigned

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment, this position will have exposure to biological hazards, including human blood products. Required to wear personal protective equipment when necessary; including but not limited to: gloves, eyewear, safety glasses, lab coat, face mask.…