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.
Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact
Responsibilities:
Complete Product Quality Assurance activities including:
Ensure the site's Environmental Monitoring Program is implemented according to established schedules and relevant procedures. Promptly identify and report any areas of concern to the appropriate stakeholders. Communicate monitoring results effectively across departments, collaborating to resolve issues as needed. This includes initiating quarantine measures for non-conforming areas and water outlets when required.
Ensure Biological Challenge testing is completed for Autoclaves as per the schedule.
Ensure timely completion of all activities related to the batch release of components and kits. This includes:
Final release of manufactured components, conducting kit pack inspections in accordance with requirements, approving projects within the LIMS system and kit release for sale.
Responsible for compiling and sending Kit batch paperwork to Notified body with respect to batch release activities.
Providing support to ensure that relevant Nonconformances, Investigations and Changes associated with the Product Quality Assurance are completed as required.
Ensure that QA retained kits are kept and controlled as per the relevant site procedures.
Ensure that the site Post Issue Stability (PIS) programme runs effectively by maintaining the system and providing the schedule to Operations.
Responsible for Proficiency scheme testing (e.g. NEQAS and EQAS) including co-ordination and follow up on receipt of samples, testing, gathering, reviewing and submitting results in a timely manner.
Provide support with changes to panel and/or reference material. This includes initiating the change and updating of the document.
Support Change notes for documentation and processes requiring update in the scope of the PQA function.
Maintain PQA metrics as required, including metrics required for product trend reviews (PMS), Proficiency scheme testing, PIS and MR.
Approach the role in a flexible manner and be prepared to adapt to requirements outside of the immediate role that are essential to the organisation.
Skill Requirements:
Knowledge and experience in Product Quality Assurance operations with emphasis on, GMP, microbiological techniques, environmental monitoring systems, running PIS systems and batch /component release.
Experience working within a Quality System environment.
Experience in Nonconformance, Investigation and Change control.
Managing timelines and prioritising workload to meet business needs.
Excellent attention to detail.
Highly motivated, proactive and solution focused.
Ability to adapt to changing priorities.
Ability to form excellent working relationships and work collaboratively within a team.
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.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at or to request an accommodation.
The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.
Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.
Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.
This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.