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Quality Control Supervisor 2 (Reagents)

United States, Northbrook 75000.00 - 100000.00 USD / Year · Job Posted May 05, 2026
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Job Description

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.

Job Responsibility

  • Deliver attainment of production schedule for finished product
  • Coordinate (development and implementation) the daily work schedule
  • Supervise associated quality control personnel
  • Establish and maintain appropriate role-specific training plans
  • Perform in-process quality control sampling and analytical testing
  • Deliver and ensure timely completion of process documentation
  • Investigate Out of Specifications
  • May oversee section cycle counts
  • May oversee the timely and accurate completion to support stability studies
  • May oversee specific calibration and maintenance of equipment and infrastructure
  • May participate in the administration of reagent certificate of quality/analysis program
  • 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
  • Identify process improvements to improve quality and efficiency
  • Participate or lead investigations and resolution of findings
  • Assist in development and/or update work instructions for new and/or improved processes
  • Develop and implement approved departmental procedures
  • Perform change control review as required
  • 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
  • May manage quality control specific labor routings and lead times for optimal accuracy
  • Provide technical guidance to quality control personnel
  • Monitor and appraise personnel performance
  • May assist in ensuring adequacy of quality control specific staffing
  • Assist in delivering timely reporting of departmental performance metrics
  • May assist in establishing annual departmental objectives
  • Other duties as assigned

Requirements

  • 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 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

What we offer

  • health benefits
  • retirement and financial wellbeing
  • time off programs
  • wellbeing support and perks

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