Quality Control Supervisor 2 (Reagents)

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

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 industrys broadest specialty diagnostic portfolios.

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

Why Join Diasorin

• 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 Summary

Assuming principal ownership of defined quality control sections and/or manufacturing product lines with responsibility to supervise associated quality control staff of moderate to high 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 Responsibilities and Duties

• 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.
• 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.

QUALIFICATIONS

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

What we offer

Salary Range

The salary range for this position is $75000 - $100000 The salary range for this role represents the numerous factors considered in the hiring decisions including but not limited to educations skills work experience certifications etc. Beyond base wages Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits retirement and financial wellbeing time off programs wellbeing support and perks. Benefits may vary by role country region union status and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award if any depends on various factors including individual and organizational performance.

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 .

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 @ email address. If you have questions about the legitimacy of a recruitment communication please contact for verification.

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