Product Support Scientist

Description:

Job Description & Responsibilities:

• Lead/support product validation activities, prepare validation protocols, and present findings.

• Conduct diagnostic assay activities for root cause investigations of product failures and complaints.

• Document technical findings and perform quantitative analysis.

• Recommend and implement improvements in methodologies, products, and processes.

• Support site quality initiatives and participate in audits.

• Maintain laboratory reagents and equipment; perform calibrations and preventive maintenance.

• Initiate Change Requests and related documentation.

• Perform other duties as assigned.

Qualifications & Skills:

• Bachelor’s degree in Science or related field with focus on Medical Technology or Clinical Laboratory Medicine.

• Experience in cGMP processes related to reagent/biologic products.

• Excellent written and verbal communication skills.

• Proficiency with Microsoft Word, Excel, PowerPoint.

Preferred:

• Certified Medical Technologist (MT(ASCP)) or equivalent.

• Experience with FDA CBER regulated licensed biologics.

Work Environment:

• Laboratory and office settings.

• Exposure to biological hazards including human blood products.

• Use of PPE including gloves, safety glasses, lab coat, mask.

Physical Demands:

• Close visual acuity for inspection, data analysis, microscope use.

• Repetitive hand movements such as typing, pipetting, documenting.