Quality Control Supervisor 2 (Reagents)

Diasorin•Northbrook, IL

6d•Onsite

About The Position

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.

Requirements

Associates of Science degree in the field of chemistry, biological sciences or related field degree
8+ years of Relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization with an Associate's 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 Bachelor's 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

Nice To Haves

Bachelor of Science degree in the field of chemistry, biological sciences or related field degree, preferred

Responsibilities

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
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.