Product Support Scientist II — Transfusion

RXinsider LTD.; Pompano Beach (FL); On-site; USD 70,000 - 100,000; Full time

Job summary

QuidelOrtho is seeking a Product Support Scientist II to join its manufacturing facility in Pompano Beach, FL. The role involves planning and executing product validations and root cause investigations for Transfusion Medicine products, with support for quality initiatives and regulatory documentation.

The candidate should have a Bachelor’s degree in Science, focus in Medical Technology/Clinical Laboratory Medicine, and at least 3 years of clinical lab experience, plus knowledge of cGMP.

Qualifications

• 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.
• 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.

Responsibilities

• Lead or provide support to Project Managers for conducting product validation activities. Prepare basic validation protocols and summary reports.
• Under general supervision, plan, design, and perform diagnostic assay activities to support Root Cause Investigations of product failure, non-conformances, and customer complaints.
• Suggest improvement to methodologies, processes, products, and systems as an outcome of projects and investigations.
• Support Site Quality initiatives. Participate in Quality audits as a representative for Product Support.
• Maintain the Product Support Laboratory reagents and equipment, including automated analyzers.
• Initiate Change Requests, Change Notices, and associated documentation for validations, product changes, and process changes.

Skills

Communication skills

cGMP processes

Laboratory experience

Education

Bachelor’s Degree in Science or related field

Medical Technology/Clinical Laboratory Medicine focus

Tools

Microsoft Word

Excel

PowerPoint

Job description

QuidelOrtho is seeking a Product Support Scientist II to join its manufacturing facility in Pompano Beach, FL. The role involves planning and executing product validations and root cause investigations for Transfusion Medicine products, with support for quality initiatives and regulatory documentation.

The candidate should have a Bachelor’s degree in Science, focus in Medical Technology/Clinical Laboratory Medicine, and at least 3 years of clinical lab experience, plus knowledge of cGMP.