diasorinsp
Product Quality Assurance Technician
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Diasorin
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!
Main Purpose:
The Product Quality Assurance Technician is responsible for supporting the final quality review and release of IVD products, ensuring all batches meet regulatory, quality, and customer requirements before release to market. The role also oversees key quality assurance activities, including environmental monitoring, Post Market surveillance support, investigation support, and continuous collaboration with Operations, Quality Control, and Regulatory teams to maintain product quality and compliance.
Responsibilities:
Product Release Activities
- Review manufacturing batch records for completeness and compliance.
- Review and update manufactured batch test results within SAP and associated quality systems as applicable (e.g., LIMS).
- Review packaging documentation and packing components prior to and post packing activities.
- Escalate non-conformances, documentation discrepancies, and compliance concerns as appropriate.
- Responsible for compiling and sending Kit batch paperwork to Notified body with respect to batch release activities.
- Verify completion of all packing batch documentation before product release to market.
- Support final batch disposition and release activities for:
- CE-marked IVDR products.
- FDA 510(k) cleared products for the US market.
- Producer-manufactured products where DiaSorin is not the legal manufacturer.
- Ensure that QA retained kits are kept and controlled as per the relevant site procedures.
- Providing support to ensure that relevant Nonconformances, Investigations, and Changes associated with the Product Quality Assurance are completed as required.
- 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.
- Initiate Change plans for documentation and processes requiring update/revision 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.
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Environmental Monitoring Oversight
- Coordinate the site water monitoring programme, ensuring departments complete scheduled sampling activities.
- Review microbiological and water testing results received from both internal departments as well as external laboratories.
- Review quarterly environmental monitoring results provided by contracted service providers.
- Investigate and coordinate repeat testing following out-of-specification or out-of-trend results.
- Support impact assessments, investigations, and corrective actions arising from environmental monitoring failures. This includes initiating quarantine measures for non-conforming areas and water outlets when required.
- Ensure timely communication of monitoring results to relevant stakeholders.
- Ensure Biological Challenge testing is completed for Autoclaves as per the schedule.
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Skill Requirements:
- Experience working in a regulated Quality Assurance, Quality Control, Manufacturing Medical Device, or Pharmaceutical environment.
- Understanding of GMP, quality systems, and batch release processes would be advantageous.
- Experience reviewing documentation and maintaining accurate records.
- Strong organizational and communication skills.
- Integrity and confidence when making quality-based decisions.
- Takes ownership of assigned activities and follows tasks through to completion.
- Works collaboratively with colleagues across Operations, QC, and Regulatory departments.
- Be able to communicate clearly and professionally at all levels.
- Approaches challenges with a positive, solutions-focused mindset.
- Demonstrates flexibility and willingness to support wider business activities when required.
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 hrtalent@diasorin.com or 1-800-328-1482 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.
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