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!

Job Scope

Responsible for manufacturing and assembly of clinical and commercial products. Operates and troubleshoots production equipment. Manufactures product per documented manufacturing instructions. Maintains records to comply with GMP's, SOP's, quality system requirements, and other regulatory requirements. Performs in-process testing to assure batches meet specifications. Works on complex assignments in a dynamic and fast paced environment where independent action and initiative are required to resolve problems. Leads and develops manufacturing technicians. Supports all applicable regulations including but not limited to FDA, ISO, IVDD, and IVDR requirements.

Key Duties and Responsibilities

• Manufacture of subassemblies, components, and/or kits per documented methods. Training requirements are listed in department specific TRQ (Training Requirements).

• In-process testing of product with ability to interpret results and perform any required adjustments to product.

• Execute validation protocols and/or experiments.

• Ability to perform investigation to identify potential root cause of an issue. Ability to identify and implement CAPA (Corrective Action and Preventative Action).

• Understand, comply, support, and enforce FDA and ISO regulatory requirements.

• Understand, comply, support, and enforce all policies and procedures.

• Lab maintenance per documented cleaning requirements.

• Inventory maintenance, replenish raw materials and supplies as required.

• Proper storage of raw materials, subassemblies, components, and kits.

• Equipment operation and maintenance per documented procedures, calibrate as required.

• Maintain product identification and traceability per Standard Operating Procedures (SOP) .

• Record required data on documents in accordance with GDP (Good Documentation Procedures) and SOP.

• Identify non-conformances and initiate required documentation. Documentation may include NC (Non-Conforming Material Report), deviation report, CAPA, investigation report, and/or risk assessments.

• Support leadership with reviewing and revising manufacturing specifications, department specific procedures, and/or create new documents as required. Implement change via DCR (Document Change Request).

• Recommend to Supervisor/Manager product or process improvements which will enhance product or business.

• Review and revise existing documents. Able to recognize deficiencies and create new documents as required.

• Inventory control - identify critical raw materials and establish and/or monitor a system to maintain control.

• Able to support the design and execution of validation protocols and experiments to enhance product, resolve product issue, and manufacturing process. Contribute to lean manufacturing and continuous improvement projects as needed.

• Close work orders and review manufacturing specification for accuracy and completeness.

• Train new employees, monitor and provide feedback to employee and management as required.

• Create and execute Production schedule per plan. Monitor progress of outstanding work orders and expedite as required to meet scheduled due date.

• Assist in special projects.

• Assist in other production areas/departments as needed.

• As needed, assist with writing reports - Investigations, Risk Assessments, Validations, Quality Plans, etc.
• Lead a team of employees within a given shift or unit. Also responsible for the overall direction, coordination, and evaluation of this unit. Carries out lead responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include performing daily work on the line, training employees; planning, assigning, and directing work; assessing team performance; making sure the team meets daily goal, and stays within cycle count; and addressing complaints and resolving problems. Responsible for enforcing all EHS policies in their span of control.

• Responsible for performing assigned tasks in accordance with the company's quality policies and procedures per the applicable quality management system regulations as defined in the Quality Manual.
• Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies. Violations of EHS regulations or policies will be handled in accordance with the established Company disciplinary process.

• Perform other duties as assigned.
• Lead a team of employees within a given shift or unit. Also responsible for the overall direction, coordination, and evaluation of this unit. Carries out lead responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include performing daily work on the line, training employees; planning, assigning, and directing work; assessing team performance; making sure the team meets daily goal, and stays within cycle count; and addressing complaints and resolving problems.
• Responsible for enforcing all EHS policies in their span of control.

Education, Experience, and Qualifications

• Requires High School Degree or higher. Experience working on complex machinery as a Sr. Production Technician or equivalent is preferred. Analytically works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Receives no instructions on routine work, general instructions on new assignments.

• Good interpersonal and verbal communication skills. Ability to read, analyze, and interpret general, technical procedures, or governmental regulations. Ability to write reports. Ability to effectively present information and respond to questions from groups of supervisors, engineers, or managers.

• Ability to add, subtract, multiply, and divide. Ability to round numbers to the nearest whole number, tenths, hundredths, or thousandths. Knowledge of metric system with ability to convert units - weight (milligram, gram, kilogram, etc.), volume (milliliter, liter, etc.), and distance (centimeter, millimeter, meter, etc.).

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

What we offer

Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.

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.