Product Support Scientist II

Ortho Clinical Diagnostics; Pompano Beach (FL); On-site; USD 75,000 - 90,000; Full time

Job summary

Ortho Clinical Diagnostics is looking for a Product Support Scientist II for its facility in Pompano Beach, Florida. The role involves product validations, root-cause investigations, and supporting quality initiatives. A minimum of a Bachelor’s Degree in Science and experience in the clinical laboratory environment are required.

Join a team committed to transforming diagnostics and supporting a healthier future. The work environment includes exposure to biological hazards and demands close visual acuity for detailed tasks.

Qualifications

• Minimum of 3 years experience in clinical laboratory or 2 in Transfusion Medicine.
• Experience in cGMP processes for reagent/biologic materials.
• Ability to perform technical findings and quantitative analysis.

Responsibilities

• Lead product validation activities and prepare validation protocols.
• Plan and perform diagnostic assay activities for investigations.
• Maintain laboratory reagents and equipment.

Skills

Communication skills

Microsoft Office proficiency

Analytical skills

Education

Bachelor’s Degree in Science or related field

Certification as Medical Technologist, MT(ASCP)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Job Summary

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.

This opportunity is for a Product Support Scientist II to work in our manufacturing facility in Pompano Beach, Florida. The Scientist participates in planning, design and execution of product validations, root‑cause investigations of product failures, and non‑conformance investigations for QuidelOrtho’s Transfusion Medicine products and associated manufacturing/production.

Responsibilities

• Lead or support 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 and implement improvements to methodologies, processes, products and systems.
• Support Site Quality initiatives and participate in quality audits as a representative for Product Support.
• Maintain the Product Support Laboratory reagents and equipment, including automated analyzers, and perform equipment calibrations and PMs as assigned.
• Initiate Change Requests, Change Notices and associated documentation for validations, product changes and process changes.
• Perform other work‑related duties as assigned.

Qualifications

• Minimum of a Bachelor’s Degree in Science or related field with an 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 may be considered in lieu of a clinical healthcare setting.
• Experience in cGMP processes associated with reagent/biologic materials and products.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Word, Excel and PowerPoint.
• Preferred: Certified Medical Technologist, MT(ASCP) or equivalent clinical laboratory scientist certification.
• Experience working with CBER (FDA) regulated licensed biologics.

Key Working Relationships

• Internal: Quality Control Lab, Quality Engineers, Quality Assurance, Regulatory Affairs, Formulations, Manufacturing/Production, Materials Management, Ops Engineering, Facilities, EHS.
• External: As assigned.

Work Environment

The work environment is representative of a manufacturing, laboratory or warehouse environment. This position will have exposure to biological hazards, including human blood products. Personal protective equipment—including gloves, eyewear, safety glasses, lab coat and face mask—will be required as necessary. The role requires close visual acuity for inspection of small parts, extensive reading, data analysis and microscope use, and repetitive hand movements such as typing, pipetting and manual documentation.

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 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 of the position. 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 [e-mail].