DiaSorin
Senior Quality Control Manager (Reagents)
DiaSorin, Chicago, Illinois, United States, 60290
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Senior Quality Control Manager (Reagents)
Published on: Nov 12, 2024 Country: United States Company: Luminex Corporation Job Category: Operations Employment type: Regular Full Time Job Scope: Manages associated Quality Control staff of moderate to high span of control and/or skill level. Leadership position that provides direct oversight to the Reagent Quality Control areas as well as leads and participates in cross-departmental/organizational teams. Responsible for ensuring facilities, resources, and equipment are in place to deliver product to the business plan. Accountable for quality control support of new product integration, stability program, process development, equipment and process validations, as well as meeting production schedules. Promotes and maintains Company Objectives and Quality Policies. 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. Key Duties and Responsibilities: Oversee direction, planning, and execution of Reagent Quality Control operations and associated personnel. Drive attainment of production schedule for finished product, qualification/processing of incoming materials, production intermediates, and stability sample testing. Develop and implement approved departmental procedures, policies, and processes. Deliver reagent quality control design transfer requirements for new and changed product through validation and market release phases. Establish, manage, and deliver timely reporting of departmental performance metrics and statistical process controls; drive actions as required. Lead/Manage or assist in planning, prioritization, development, and implementations of new local and multi-department improvement initiatives, policies, and programs. Deliver efficiency, cost reduction, and quality improvement projects within scope of department as defined to organization's goals. Lead or participate in sustaining projects for improvement of processes, global harmonization, infrastructure, product specifications, process/test methods, analysis tools, and business systems. Oversee and participate in Change Control Board responsibilities for Reagent Quality Control as needed. Lead or participate in investigations and resolution of findings impacting the Reagent Manufacturing Organization identified through audits, non-conformances, corrective/preventive actions, or customer complaint escalations. Establish and maintain appropriate departmental role-specific training plans; ensure that each team member is properly trained on systems, processes and equipment. Identifies and manages annual departmental capital, headcount, and expense budgeting requirements. Monitor and appraise personnel performance; develop and advance personnel consistent with needs of organization. Drive departmental strategic planning encompassing organization, equipment, and facilities. Recommend and/or manage development of new departmental process capabilities and equipment. Maintain personal compliance and facilitate departmental compliance with the Luminex Quality System. May manage Material Review Board and deliver operational nonconformance disposition approval. May lead the administration of reagent certificate of quality/analysis program to include certificate issuance. 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. May administer 24/7 environmental monitoring infrastructure and program for specialized storage areas and ensure continuous readiness and effectively respond to environmental monitoring notifications. Other duties as assigned. Education, Experience, and Qualifications: Bachelor's Degree Field of chemistry, biological sciences, or related field degree required. 8+ Years Relevant Quality Operations leadership experience required. 10+ Years Relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization with a Bachelor’s Degree required. Mathematics aptitude (High proficiency). ISO 13485 and FDA Quality Systems knowledge (High proficiency). Proficiency in use of process based Manufacturing Resource Planning systems such as Oracle or SAP (High proficiency). Proficiency in the use of Product Life Cycle Management tools (High proficiency). Proficiency in data analysis tools and technical writing (High proficiency). Knowledge in clean room operations, molecular grade processing/purified water systems (High proficiency). Applied knowledge of process, equipment, and test method validations (Medium proficiency). Functional knowledge of nucleic acid, immunoassay, and serology assay chemistry (Medium proficiency). Statistical aptitude (Medium proficiency). Quality Certification such as ASQ CQM, CQE, or Sixth Sigma Certification preferred. Travel Requirements: 10% Travel may be required. What We Offer: Receive a competitive wages and benefits package as you grow your career at Diasorin. Join our team and discover how your work can impact the lives of people all over the world. Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation. The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.
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Published on: Nov 12, 2024 Country: United States Company: Luminex Corporation Job Category: Operations Employment type: Regular Full Time Job Scope: Manages associated Quality Control staff of moderate to high span of control and/or skill level. Leadership position that provides direct oversight to the Reagent Quality Control areas as well as leads and participates in cross-departmental/organizational teams. Responsible for ensuring facilities, resources, and equipment are in place to deliver product to the business plan. Accountable for quality control support of new product integration, stability program, process development, equipment and process validations, as well as meeting production schedules. Promotes and maintains Company Objectives and Quality Policies. 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. Key Duties and Responsibilities: Oversee direction, planning, and execution of Reagent Quality Control operations and associated personnel. Drive attainment of production schedule for finished product, qualification/processing of incoming materials, production intermediates, and stability sample testing. Develop and implement approved departmental procedures, policies, and processes. Deliver reagent quality control design transfer requirements for new and changed product through validation and market release phases. Establish, manage, and deliver timely reporting of departmental performance metrics and statistical process controls; drive actions as required. Lead/Manage or assist in planning, prioritization, development, and implementations of new local and multi-department improvement initiatives, policies, and programs. Deliver efficiency, cost reduction, and quality improvement projects within scope of department as defined to organization's goals. Lead or participate in sustaining projects for improvement of processes, global harmonization, infrastructure, product specifications, process/test methods, analysis tools, and business systems. Oversee and participate in Change Control Board responsibilities for Reagent Quality Control as needed. Lead or participate in investigations and resolution of findings impacting the Reagent Manufacturing Organization identified through audits, non-conformances, corrective/preventive actions, or customer complaint escalations. Establish and maintain appropriate departmental role-specific training plans; ensure that each team member is properly trained on systems, processes and equipment. Identifies and manages annual departmental capital, headcount, and expense budgeting requirements. Monitor and appraise personnel performance; develop and advance personnel consistent with needs of organization. Drive departmental strategic planning encompassing organization, equipment, and facilities. Recommend and/or manage development of new departmental process capabilities and equipment. Maintain personal compliance and facilitate departmental compliance with the Luminex Quality System. May manage Material Review Board and deliver operational nonconformance disposition approval. May lead the administration of reagent certificate of quality/analysis program to include certificate issuance. 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. May administer 24/7 environmental monitoring infrastructure and program for specialized storage areas and ensure continuous readiness and effectively respond to environmental monitoring notifications. Other duties as assigned. Education, Experience, and Qualifications: Bachelor's Degree Field of chemistry, biological sciences, or related field degree required. 8+ Years Relevant Quality Operations leadership experience required. 10+ Years Relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization with a Bachelor’s Degree required. Mathematics aptitude (High proficiency). ISO 13485 and FDA Quality Systems knowledge (High proficiency). Proficiency in use of process based Manufacturing Resource Planning systems such as Oracle or SAP (High proficiency). Proficiency in the use of Product Life Cycle Management tools (High proficiency). Proficiency in data analysis tools and technical writing (High proficiency). Knowledge in clean room operations, molecular grade processing/purified water systems (High proficiency). Applied knowledge of process, equipment, and test method validations (Medium proficiency). Functional knowledge of nucleic acid, immunoassay, and serology assay chemistry (Medium proficiency). Statistical aptitude (Medium proficiency). Quality Certification such as ASQ CQM, CQE, or Sixth Sigma Certification preferred. Travel Requirements: 10% Travel may be required. What We Offer: Receive a competitive wages and benefits package as you grow your career at Diasorin. Join our team and discover how your work can impact the lives of people all over the world. Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation. The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.
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