Lead, Production Technician

Overview

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 develop innovative diagnostic assays and instruments 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 widest-ranging provider of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

• Impactful Work:
  When you join Diasorin, you become part of a team dedicated to improving lives. Your contributions directly impact patient care and make a meaningful difference.
• Global Reach & Innovation:
  Our work transcends borders, enabling collaboration with colleagues worldwide and contributing to global healthcare solutions at the forefront of the diagnostic industry.
• Diverse and Inclusive Culture:
  We value diversity and offer a supportive, collaborative environment where everyone can thrive. If you are passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin can be the place for you.

Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

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 GMPs, SOPs, 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 CMD/CAS requirements.

• 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.
• Investigate to identify potential root causes of issues. 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 SOPs.
• Record required data on documents in accordance with GDP and SOP.
• Identify non-conformances and initiate required documentation (e.g., NCMR, deviation report, CAPA, investigation report, risk assessments).
• Support leadership with reviewing and revising manufacturing specifications and procedures; create new documents as required. Implement changes via DCR (Document Change Request).
• Recommend product or process improvements to enhance product or business.
• Review and revise existing documents; recognize deficiencies and create new documents as required.
• Inventory control – identify critical raw materials and maintain control systems.
• Support design and execution of validation protocols and experiments; contribute to lean manufacturing and continuous improvement projects as needed.
• Close work orders and review manufacturing specifications for accuracy and completeness.
• Train new employees; monitor and provide feedback to employees and management as required.
• Create and execute production schedule per plan; monitor progress and expedite as needed to meet due dates.
• Assist in special projects and other…