The Role:

As we continue to grow as QuidelOrtho, we are seeking a Senior Scientist, Raw Material. Organizes and leads moderately complex projects primarily focused on the validation of new raw materials (chemicals and biologicals) that are used in the manufacture of VITROS MicroSlide, MicroSlide Fluids and MicroTip products. The Senior Scientist will provide direct technical support to the material validations by conducting analytical testing and analysis that includes but is not limited to raw material feasibility assessments, raw material quality investigations and manufacturing process troubleshooting. They will help identify raw material characteristics that are critical to assay performance and may work directly with suppliers to help develop and implement specifications to ensure product quality.

The Senior Scientist will work both independently and as a team member to conduct raw material and manufactured product root-cause investigations using QIC6 methodology. Define and develop test designs to evaluate the magnitude of the failure on product performance and assess residual product risk. They will analyze data and author a technical report which will include a recommendation for the fitness of use of the product. This position is located on-site in Rochester, NY.

The Responsibilities:

• Plans, executes and documents feasibility trials for new raw materials and/or manufacturing materials.
• Creates and/or updates existing risk assessments (e.g. FMEA and Product Hazard Analysis).
• Writes validation plans and reports.
• Analytical testing for raw material validation projects and quality investigations.
• Effectively communicates results to management and cross-functional teams; summarizes and presents project status updates to senior leadership team as needed.
• Performs other work-related duties as assigned.

Required:

• Bachelor’s degree in scientific field (Chemistry, Biology, Biotechnology, or Chemical Engineering field preferred.
• 1-3 years of experience working in a regulated environment.
• Validation experience required, including authoring plans, reports and analyzing data using Minitab or equivalent statistical software.
• Demonstrated experience conducting root cause investigations using QIC6, Process Excellence or equivalent methodologies.
• Experience performing analytical testing (including but not limited to UV-VIS, FTIR, Liquid and Gas chromatography).
• Experience with Ortho Change Control system is preferred.
• Strong organizational skills with the ability to multi-task and manage multiple projects.
• Effective communication and presentation skills.
• Flexibility in schedule based on business need.
• Adhering to all quality, regulatory and safety guidelines.
• Staying current with individual and company training plan.
• Accountable for clear and accurate documentation within QuidelOrtho quality system

The Key Working Relationships:

• Internal Partners: Management, Production Engineers, Quality Engineers, R&D.
• External Partners: Material suppliers.