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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