Product Support Scientist II

RXinsider LTD.; Pompano Beach, Northern (FL, KY); Hybrid; USD 70,000 - 95,000; Full time

Job summary

QuidelOrtho invites applications for a Product Support Scientist II at its Pompano Beach, Florida facility. The role spans validation planning, root cause investigations of product failures, and non-conformance handling.

The position requires a science degree and relevant laboratory experience within a regulated environment. You will work under general supervision to ensure quality across Transfusion Medicine products, support project teams, maintain lab instruments, and contribute to process

Qualifications

• Bachelor's degree in science or related field is required.
• Educational focus in Medical Technology or Clinical Laboratory Medicine.
• 3+ years in a clinical lab or 2 years in transfusion medicine preferred.
• Experience with cGMP processes and reagents/biologics.
• Strong written and verbal communication skills; documentation proficiency.
• Proficiency with Word, Excel and PowerPoint is essential.

Responsibilities

• Lead or support project managers in product validation activities.
• Plan, design and perform diagnostic assays to support investigations.
• Provide evidence of technical findings and quantitative analysis.
• Suggest process and method improvements based on investigations.
• Support Quality initiatives and participate in audits.
• Maintain reagents and equipment and perform calibrations as needed.
• Initiate change requests and associated documentation.

Skills

Communication skills

Clinical laboratory experience

cGMP knowledge

Laboratory documentation

MS Office proficiency

Education

Bachelor's Degree in Science

Medical Technology/Clinical Laboratory focus

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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 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 QuidelOrtho's Transfusion Medicine products and associated manufacturing/production.

This position is in Pompano Beach, Florida.

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 changes.


• Perform other work-related duties as assigned.

The Individual

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.

Key Working Relationships

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

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. 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, and manual writing/documentation.

Equal Employment Opportunities

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 [e-mail].