Quality Control Supervisor, Instruments - 2nd Shift

• 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.

• 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.

• 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)

DiaSorin