Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.
Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."
Why Join Diasorin?
**Impactful Work**: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
**Global Reach & Innovation**: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
**Diverse and Inclusive Culture**: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.
**Join Our Team**: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Job Scope
Supports project activities for assay development of LIAISON® family for the following product categories:
new product;
new generation of an already existing product;

change of already existing product (change of technology / change of critical supplier).
Help with the definition of the product and process risks associated with the product development activities, in collaboration with the site ToT groups
Acts in compliance with Product Design requirements and Product Development Master Plan.
Key **Responsibilities**:
He/She helps with the definition of master formulas of kit components and assay scheme of LIAISON® prototypes.
He/She updates the Team Managers on progression of activities from technical and timelines perspective.
He/She helps with the verification of critical aspects and requirements of bench prototypes in compliance with internal regulations (GOP-SOP) and external and internal quality standards.
He/She helps witht the definition of product claims in compliance with internal regulations (GOP-SOP) and external and internal quality standards
He/She helps with project documentation.
He/She collaborates to panels and raw material definition required for project activities and industrialization phase.
He/She collaborates with DiaSorin Research Center during the evaluation of prototypes and raw materials transferred to DiaSorin sites.
He/She collaborates with the Regulatory departments of DiaSorin sites for the drafting the pre-submission documents (pre-IDE) and the submission documents to notified bodies.

He/She collaborates on technical analysis for complaints and / or trends of product performances.
He/She supports the activities assigned to the Laboratory Staff of the Team
Education, Experience, and Qualifications
Degree in scientific disciplines.
Two-year experience (minimum) in DiaSorin or in equivalent diagnostic or pharmaceutical companies.
Knowledge of mandatory requirements for in vitro "Diagnostic Medical Devices".
Skilled with Office Tools (word, Excel)
Basic Statistical analysis with MiniTab or equivalent softwares
DoE basic skills
Proactive, flexibility, able to support decisions and communications.
Able to act within timely manner and precision for the team.
Fluent in written and spoken Italian and English.
**Minimum requirements listed above**:
GMP and Site Quality System;
SOP 04.0001, Product Design, Change, Transformation Process;
**Immunoassays**: the coating;
**Immunoassays**: the Tracer
GOP23.7025, Immunoassays Product Analytical Validation;
GOP23.7026, Stability Testing of Immunoassay
Assay Programming Guide LIAISON XL and LIAISON XS
Training SmartSolve (Doc.Module, Training Module, Change Module)
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.
The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the p

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