DiaSorin
LEAD REAGENT QUALITY CONTROL ASSOCIATE
DiaSorin, Chicago, Illinois, United States, 60290
Select how often (in days) to receive an alert:Lead Reagent Quality Control Associate
Published on:
Nov 9, 2024Country:
United StatesCompany:
Luminex CorporationJob Category:
OperationsEmployment type:
Regular Full TimeJob Scope:• Leading and participating in QC processes to support new product design transfer, process development, process validations, equipment validations and the investigation and resolution of product/process issues.• Creating or updating QC instructions or SOPs and perform the associated engineering change control.• Being a Rees administrator, ensuring compliance, issuing reports, and implementing changes in the Rees environmental monitoring system.• Task-specific training and mentoring of other Reagent QC personnel.• Executing Quality Control (QC) processes associated with production.• Assisting in core functions involving purchased product, reagent stability program, retention program, and departmental calibration and maintenance.• Frequent intra-department interaction as well as frequent inter-department interfaces with Quality Assurance, Reagent Manufacturing, Design Transfer, Purchasing, Document Control, and Research and Development.• Being able to multi-task, meet deadlines, maintain flexibility, and work as a team member.Key Duties and Responsibilities:Deliver timely and accurate Quality Control testing for Reagent Bioassay and core Consumable standard inventory and build-to-order products.Deliver timely and accurate completion of quality control and manufacturing process documentation including related business system transactions.Deliver QC specific work order scheduling to achieve attainment of production and project due dates and optimal utilization of resources.Assist in developing and implementing daily work schedule, priorities, and task delegation within QC.Responsible for stability study sample planning, scheduling, and processing.Lead and participate in program to sustain orderliness and cleanliness within related quality control and manufacturing areas through routine sorting, labeling, systematic cleaning, and standardizing.Lead and assist in monitoring of departmental supplies and equipment required for testing; generate Purchase Orders as needed.Responsible for the scheduling of outsource testing and servicesResponsible for the scheduling and preparation of laboratory reagents for internal useVerify Reagent Quality Control or Manufacturing documentation.Prepare and verify Reagent Certificates of Quality.Issue Reagent Certificates of Quality.Document and complete non-conformances.Participate in Material Review Board as required.Conduct quality control record Completeness ReviewsParticipate in or conduct applicable departmental and interdepartmental trainingMaintain current training to standard operating procedures, quality control instructions (QCIs), and applicable changes affecting Reagent Quality Control.Deliver timely and accurate completion of inventory cycle counts for select sub-inventories.Perform Associate II, I or Technician responsibilities as requiredPerform training of QC Technician, QC Associate, Associate II, and Senior Associate personnel to task-specific operations, operating procedures, and standard operating procedures.Respond appropriately to environmental monitoring notifications of specialized storage areas.Act as Rees Environmental Monitoring System Administrator; monitor system, issue reports and monitor trends, implement changes within system, respond to departmental requests and provide setup and training. Correspond with Rees Scientific and other departments as necessary.Collect/compile data to monitor, report, and take action for out of control trends based on statistical process control limits and established performance criteria.Responsible for the compilation and analysis of technical deliverables.Plan and execute projects; compile, report, and present data and project conclusions.Assist with quality control integration of new product and process in collaboration with Design Transfer and Process Engineering team.Support design transfer with process improvement projects.Revise QCIs, manufacturing instructions, and standard operating procedures as required.Write basic equipment validations plans and reportsParticipate /execute equipment and process validations.Responsible for the creation and revision of standard operating procedures (SOPs), test methods, manufacturing instructions and deviations.Execute and assist in departmental document change control and engineering change control activities.Lead and assist in continuous improvement projects.Lead or participate in the effective prioritization, investigation, and resolution of findings impacting Reagent QC initiated through audits, non-conformances, corrective/preventive actions, or customer complaint escalation.Assist in planning and executing projects targeting efficiency, cost reduction, and quality improvements.Participate in infrastructure improvement projects affecting quality control.Assist in establishing annual CAPP objectives; fulfill individual CAPP objectives.Attend departmental planning and informational meetings as required representing Quality Control.Maintain personal compliance with Luminex Quality System including FDA, USDA, and ISO 13485:2012 requirements; facilitate sectional compliance with the Quality System.Adhere to safety, disposal and gowning requirements applicable to department; facilitate departmental safety compliance.Participate in additional quality activities as required.Interface with other departments as required.Other duties as assigned.Education, Experience, and Qualifications:Bachelor's Degree in a Life Sciences, Chemistry, Medical Technology, or Biosciences field.Experience in quality control or manufacturing laboratory experience in a Life Sciences, Chemistry, Medical Technology, or Biotechnology field.Quality Control experience in a relevant ISO 13485; 2012 and or USDA/FDA regulated industry setting.Experience in immunoassay, proteomic and nucleic assay chemistryRelevant combinations of education, experience, training, and merit may be considered upon the review of Senior Director of Reagent Operations.Training and SkillsThorough knowledge of ISO 13485:2012, FDA, and USDA Quality System requirementsThorough knowledge of immunoassay, proteomic and nucleic assay chemistry.Proficient in use of process based Manufacturing Resource Planning systems such as Oracle or SAPProficient in the use of Product Lifecycle Management tools, including applied knowledge of Engineering Change Control.Proficient in Microsoft Word, Excel, and PowerPointProficient in written communication including document creation and revision and technical writing. Knowledge of Statistical Process control and applicationHigh mathematical and statistics aptitude including proficient data analysis skillsKnowledge of Six Sigma and Lean Manufacturing processes desiredKnowledge of statistical process controlKnowledge in cleanroom operations and purified water systemsKnowledge of industry standard practices for Biosafety Level 2 areasAbility to handle the pressure of meeting tight deadlines and adapting to rapidly changing priorities.Highly organized with proven time-management skills and prioritization skillsAbility to work independently and with minimal supervision
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Published on:
Nov 9, 2024Country:
United StatesCompany:
Luminex CorporationJob Category:
OperationsEmployment type:
Regular Full TimeJob Scope:• Leading and participating in QC processes to support new product design transfer, process development, process validations, equipment validations and the investigation and resolution of product/process issues.• Creating or updating QC instructions or SOPs and perform the associated engineering change control.• Being a Rees administrator, ensuring compliance, issuing reports, and implementing changes in the Rees environmental monitoring system.• Task-specific training and mentoring of other Reagent QC personnel.• Executing Quality Control (QC) processes associated with production.• Assisting in core functions involving purchased product, reagent stability program, retention program, and departmental calibration and maintenance.• Frequent intra-department interaction as well as frequent inter-department interfaces with Quality Assurance, Reagent Manufacturing, Design Transfer, Purchasing, Document Control, and Research and Development.• Being able to multi-task, meet deadlines, maintain flexibility, and work as a team member.Key Duties and Responsibilities:Deliver timely and accurate Quality Control testing for Reagent Bioassay and core Consumable standard inventory and build-to-order products.Deliver timely and accurate completion of quality control and manufacturing process documentation including related business system transactions.Deliver QC specific work order scheduling to achieve attainment of production and project due dates and optimal utilization of resources.Assist in developing and implementing daily work schedule, priorities, and task delegation within QC.Responsible for stability study sample planning, scheduling, and processing.Lead and participate in program to sustain orderliness and cleanliness within related quality control and manufacturing areas through routine sorting, labeling, systematic cleaning, and standardizing.Lead and assist in monitoring of departmental supplies and equipment required for testing; generate Purchase Orders as needed.Responsible for the scheduling of outsource testing and servicesResponsible for the scheduling and preparation of laboratory reagents for internal useVerify Reagent Quality Control or Manufacturing documentation.Prepare and verify Reagent Certificates of Quality.Issue Reagent Certificates of Quality.Document and complete non-conformances.Participate in Material Review Board as required.Conduct quality control record Completeness ReviewsParticipate in or conduct applicable departmental and interdepartmental trainingMaintain current training to standard operating procedures, quality control instructions (QCIs), and applicable changes affecting Reagent Quality Control.Deliver timely and accurate completion of inventory cycle counts for select sub-inventories.Perform Associate II, I or Technician responsibilities as requiredPerform training of QC Technician, QC Associate, Associate II, and Senior Associate personnel to task-specific operations, operating procedures, and standard operating procedures.Respond appropriately to environmental monitoring notifications of specialized storage areas.Act as Rees Environmental Monitoring System Administrator; monitor system, issue reports and monitor trends, implement changes within system, respond to departmental requests and provide setup and training. Correspond with Rees Scientific and other departments as necessary.Collect/compile data to monitor, report, and take action for out of control trends based on statistical process control limits and established performance criteria.Responsible for the compilation and analysis of technical deliverables.Plan and execute projects; compile, report, and present data and project conclusions.Assist with quality control integration of new product and process in collaboration with Design Transfer and Process Engineering team.Support design transfer with process improvement projects.Revise QCIs, manufacturing instructions, and standard operating procedures as required.Write basic equipment validations plans and reportsParticipate /execute equipment and process validations.Responsible for the creation and revision of standard operating procedures (SOPs), test methods, manufacturing instructions and deviations.Execute and assist in departmental document change control and engineering change control activities.Lead and assist in continuous improvement projects.Lead or participate in the effective prioritization, investigation, and resolution of findings impacting Reagent QC initiated through audits, non-conformances, corrective/preventive actions, or customer complaint escalation.Assist in planning and executing projects targeting efficiency, cost reduction, and quality improvements.Participate in infrastructure improvement projects affecting quality control.Assist in establishing annual CAPP objectives; fulfill individual CAPP objectives.Attend departmental planning and informational meetings as required representing Quality Control.Maintain personal compliance with Luminex Quality System including FDA, USDA, and ISO 13485:2012 requirements; facilitate sectional compliance with the Quality System.Adhere to safety, disposal and gowning requirements applicable to department; facilitate departmental safety compliance.Participate in additional quality activities as required.Interface with other departments as required.Other duties as assigned.Education, Experience, and Qualifications:Bachelor's Degree in a Life Sciences, Chemistry, Medical Technology, or Biosciences field.Experience in quality control or manufacturing laboratory experience in a Life Sciences, Chemistry, Medical Technology, or Biotechnology field.Quality Control experience in a relevant ISO 13485; 2012 and or USDA/FDA regulated industry setting.Experience in immunoassay, proteomic and nucleic assay chemistryRelevant combinations of education, experience, training, and merit may be considered upon the review of Senior Director of Reagent Operations.Training and SkillsThorough knowledge of ISO 13485:2012, FDA, and USDA Quality System requirementsThorough knowledge of immunoassay, proteomic and nucleic assay chemistry.Proficient in use of process based Manufacturing Resource Planning systems such as Oracle or SAPProficient in the use of Product Lifecycle Management tools, including applied knowledge of Engineering Change Control.Proficient in Microsoft Word, Excel, and PowerPointProficient in written communication including document creation and revision and technical writing. Knowledge of Statistical Process control and applicationHigh mathematical and statistics aptitude including proficient data analysis skillsKnowledge of Six Sigma and Lean Manufacturing processes desiredKnowledge of statistical process controlKnowledge in cleanroom operations and purified water systemsKnowledge of industry standard practices for Biosafety Level 2 areasAbility to handle the pressure of meeting tight deadlines and adapting to rapidly changing priorities.Highly organized with proven time-management skills and prioritization skillsAbility to work independently and with minimal supervision
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