QA Technician II

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry's broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

• Build What Matters
  Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale
  Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People-Centered Culture
  Thrive in a culture that values accountability, inclusion, and continuous development.

Job Scope

The Quality Assurance (QA) Technician II is responsible for performing detailed review and approval of Device History Records (DHRs) to ensure products are manufactured and documented in compliance with applicable regulatory requirements, quality standards, and internal procedures. This role serves as an experienced QA resource supporting manufacturing operations through documentation review, discrepancy resolution, and continuous improvement activities to ensure timely product release and maintenance of the quality system.

Responsibilities and Duties

• Inspect and verify product labels and insert, perform data review for material intermediate and component releases, label reconciliation in DHR, complete release documentation (release forms and status labels)
• Conduct review of documentation in accordance with released procedures and GxP standards (GDP, GMP). Verification for compliance, including raw material status, calibration, etc.
• Attend interdepartmental meetings to support and coordinate product release, such as MRB.
• Assist with scanning and archiving. Create certificates of compliance for product release.
• Track key performance metrics related to DHR review and release.
• Prepare documents for monthly reviews.
• Conduct internal audits.
• Assist with Material Review Board (MRB).
• Open non-conformances (NCs) in the applicable system
• Other duties as assigned.

Education, Experience and Qualifications

• H.S. Diploma/GED
• 2-3 Years Relevant experience in a Good Manufacturing Practices (GMP) environment Preferred

Licenses and Certifications Licenses

• Working knowledge of GMP, GDP, and regulatory requirements (FDA, ISO 13485)
• Ability to work with minimal supervision and be detail-oriented
• Ability to read, speak, and write the English language
• Strong written and verbal communication
• PC literate
• Ability to apply sampling techniques (preferred)

Working Environment

• Constantly Occasional lifting of 30 lbs.
• Lifting, climbing, stopping, kneeling and some reaching

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

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, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact hr@diasorin.com.

Recruitment Fraud Notice

Diasorin never requests payment, financial information, or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @diasorin.com email address. If you have questions about the legitimacy of a recruitment communication, please contact hr@diasorin.com for verification.

Unauthorized third-party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department.