• 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.

Job Scope

• Assuming principal ownership of defined quality control sections and/or manufacturing product lines with responsibility to supervise associated quality control staff of low to moderate span of control and /or skill level
• Accountable for test of product according to production schedules for products including quality control support of new product integration, stability program, process development, equipment validations, and process validations.
• Leads and engages team employees, plans, coordinates, and supervises the daily activities of their assigned quality control section and/or product lines to ensure efficient production. Setting the daily schedule, priorities, and task delegation and managing resources to execute the production schedule.
• Frequent intra-department interaction as well as frequent inter-department interfaces with Quality Assurance, Manufacturing, Production Planning, Purchasing, Finance, Document Control, Shipping/Receiving, and Product Development
• Manufacturing environment is a high complexity, small/large run production environment. Responsible for standard and custom Luminex reagent product lines manufactured in an environment that is ISO certified and includes products that are FDA regulated.

Key Duties and Responsibilities

• Deliver attainment of production schedule for finished product, qualification/processing of incoming materials, production intermediates, and stability samples.
• Coordinate (development and implementation) the daily work schedule, priorities, and task delegation.
• Supervise associated quality control personnel.
• Establish and maintain appropriate role-specific training plans; ensure that each team member is properly trained on systems, processes and equipment.
• Perform in-process quality control sampling and analytical testing.
• Deliver and ensure timely completion of process documentation and related business system transactions.
• Investigate Out of Specifications, document non-conformances, and participate and/or lead in Material Review Board as required.
• May oversee section cycle counts; deliver timely completion of cycle counts and physical inventory.
• May oversee the timely and accurate completion to support stability studies, process development, and process validations.
• May oversee specific calibration and maintenance of equipment and infrastructure.
• May participate in the administration of reagent certificate of quality/analysis program to include certificate issuance.
• May administer 24/7 environmental monitoring program for specialized storage areas.
• Participate/execute equipment and process validations as needed.
• Participates in the integration of new products and processes into the Manufacturing organization; participates in validation and integration of new products and processes; participates in design transfer teams as required.
• Identify process improvements to improve quality and efficiency. Participate in sustaining projects for improvement of manufacturing processes, infrastructure, product specifications, process/test equipment/fixtures, analysis tools, and business systems.
• Participate or lead investigations and resolution of findings impacting the reagent quality control/manufacturing organization identified through audits, non-conformances, corrective/preventive actions, or customer complaints escalation.
• Assist in development and/or update work instructions for new and/or improved processes.
• Develop and implement approved departmental procedures, policies, and processes.
• Perform change control review as required to including Engineering Change Orders, Document Change Control, Manufacturing Change Control, and Deviations. Take ownership of section task-specific and change control training.
• Maintain cleanliness and integrity of QC laboratory and storage areas.
• Maintain personal compliance and facilitate departmental compliance with the Quality Management System.
• Adhere to safety, disposal, and gowning requirements; facilitate departmental compliance.
• May manage quality control specific labor routings and lead times for optimal accuracy; facilitate definition of labor routings and lead times for new product introductions.
• Provide technical guidance to quality control personnel.
• Develop and implement approved departmental procedures, policies, and processes.
• Monitor and appraise personnel performance; develop and advance personnel consistent with needs of organization.
• May assist in ensuring adequacy of quality control specific staffing and pursuing meaningful and selective hiring of human resources dictated by business.
• Assist in delivering timely reporting of departmental performance metrics and process statistics.
• May assist in establishing annual departmental objectives.
• Other duties as assigned.

Education, Experience, and Qualifications

• Associate's Degree Associates of Science degree in the field of chemistry, biological sciences or related field degree with equivalent amount of experience required
• Bachelor's Degree Bachelor of Science degree in the field of chemistry, biological sciences or related field preferred
• 5+ Years Relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization with a Bachelor's Degree required
• 8+ Years Relevant experience required with an Associate Degree required
• 2+ Years Relevant Manufacturing Operations leadership experience required
• Mathematics aptitude (High proficiency)
• Knowledge of clean/HEPA filtered manufacturing environments (Low proficiency)
• Knowledge of purified water systems (Low proficiency)
• Statistical aptitude (Low proficiency)
• ISO 13485 and FDA Quality Systems knowledge (Medium proficiency)
• Proficiency in use of process based Manufacturing Resource Planning systems such as Oracle or SAP (Medium proficiency)
• Proficiency in the use of Product Life Cycle Management tools (Medium proficiency)

Travel Requirements

• 10% Limited travel may be required

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.