Manager, Quality Control
|Northbrook, Illinois - United States
$95,000.00 - $110,000.00 - US Dollars - Yearly
|15% bonus, solid benefits plan
WHY IS THIS A GREAT OPPORTUNITY?
The company really tries to promote from within, they offer truly excellent benefits and they have had strong growth in 2020
Assume principal ownership and leadership 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 testing according to production schedules for products including quality control support of new product integration, stability program, process development, equipment validations, and process validations Set the daily schedule, priorities, and task delegation and manage resources to execute the production schedule. Lead QC representative in cross-departmental/organizational teams. Promote and maintain Company Objectives and Quality Policies. 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.
What you will do
- Develop, budget, and manage QC department plans.
- Manage associated QC personnel and coordinate work schedule and priorities.
- Establish and maintain appropriate departmental role-specific training plans; ensure that each team member is properly trained on systems, processes, and equipment.
- Drive attainment of production schedule for finished product, qualification/processing of incoming materials, production intermediates, and stability samples.
- Develop and implement approved departmental procedures, policies, and processes.
- Deliver timely completion of process documentation and related business system transactions; enforce timely departmental completion.
- Investigate Out of Specifications, document non-conformances, and participate and/or lead in Material Review Board as required. Deliver key disposition approval as required.
- Participate in the integration of new products, methods and processes into the Manufacturing organization; participate in validation and design transfer teams as required.
- Deliver timely reporting of departmental performance metrics and statistical process controls; drive actions as required.
- Identify process improvements to improve quality, efficiency, and cost. Participate or lead in sustaining projects for improvement of processes, global harmonization, infrastructure, product specifications, process/test methods, analysis tools, and business systems.
- Develop or update work instructions for new and/or improved processes.
- Support change requirements including Engineering Change Orders, Document Change Control, Manufacturing Change Order and Deviations. Take ownership of task-specific and change control training.
- Participate or lead investigations and resolution of findings impacting the Reagent Manufacturing Organization identified through audits, non-conformances, corrective/preventive actions, or customer complaint escalations.
- Maintain cleanliness and integrity of QC laboratory and storage areas.
- Participate in departmental and interdepartmental training; maintain current training to standard operating procedures per matrix, work instructions, and applicable changes
- Ensure adequacy of quality control specific staffing and pursuing meaningful and selective hiring of human resources as dictated by business.
- Provide technical guidance to QC personnel.
- Monitor and appraise personnel performance; develop and advance personnel consistent with needs of organization.
- Maintain personal compliance and facilitate departmental compliance with the Luminex Quality System.
- Adhere to safety, disposal, and gowning requirements; facilitate departmental compliance.
- May oversee section cycle counts; deliver timely completion of cycle counts and physical inventory.
- May lead the timely and accurate completion to support stability studies, process development, and process validations including approval of associated protocols and reports.
- May oversee specific departmental calibration and maintenance of equipment and infrastructure.
- May lead the administration of reagent certificate of quality/analysis program to include certificate issuance.
- May administer and oversee 24/7 environmental monitoring program for specialized storage areas.
- 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.
- Perform in-process quality control sampling and analytical testing.
- Other duties as assigned.
- Associates of Science degree in the field of chemistry, biological sciences or related field degree required and 10+ Years Relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization
- Bachelor's Degree Bachelor of Science degree in the field of chemistry, biological sciences or related field degree preferred and 8+ Years Relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization
- 3+ Years Relevant Quality Operations leadership experience required
Training and Skills
- Mathematics aptitude (High proficiency)
- ISO 13485 and FDA Quality Systems knowledge (Medium proficiency)
- Knowledge in clean room operations, molecular grade processing/purified water systems (Medium proficiency)
- Proficiency in use of process based Manufacturing Resource Planning systems such as Oracle or SAP (Medium proficiency)
- Functional knowledge of nucleic acid, immunoassay, and serology assay chemistry (Medium proficiency)
- Proficiency in the use of Product Life Cycle Management tools (Medium proficiency)
- Statistical aptitude (Medium proficiency)
- Proficiency in data analysis tools and technical writing (Medium proficiency)
- 10% Travel may be required.
University - Bachelor's Degree/3-4 Year Degree