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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLE PHONE NUMBER AVAILABLEEDUCATIONKeller Graduate School of Management Street Address
Masters in Business Administration/Project ManagementChicago State University Street Address
Bachelors of Science (Biology)Olive Harvey College 1992Associates of Science (Biology)Trainco Business School 1983Secretarial ScienceQuality Assurance Specialist (Georgia Nut Company)Skokie, IL 11/19/2018 - presentResponsible to report any food safety and quality problems to personnel with authority to initiate action.Perform QA in-process inspections for each department/line once per shift by checking the following: production paperwork, retain sample, code date/lot number/best by date, weight check documentation, metal detection documentation, label, color code, department cleanliness employee GMP practice and checking for any potential allergen cross-contamination.Perform scale checks once per day.Holds:Place on hold materials due to quality, food safety per Hold PolicySend out electronic hold reports to through SharePoint and transfer PQ product to 100#Release products which are on hold when approval is receivedGenerate disposal reports for materials on hold to be disposedPerform hold level 1 and level2 inventoryPerform verifications on DVU (2 Log and 5 Log)Perform alarm checks for roastersPerform metal detector check as an audit during productionDVU:Perform changeover validation on production lines and perform clean equipment/ATP swabbing on equipment after sanitationPerform environmental swabbing during manufacturingPerform yearly allergen validationMaintain inventory of QA suppliesMake retain samples for ProductionConduct internal plant auditsConduct glass and brittle plastic auditPerform magnet pull test annuallyPerform metal detection test on metal detectable ear plugs and band aids twice a yearMonitor GMP on the floor and send out daily report of issues notedTrain new QA Techs and QA SpecialistsGenerate maintenance work requestsShut down lines/department when a serious food safety issue is noticedFiling QA documentsConduct any other functions as required by the QA departmentCheck oil FFA and water chlorineCover for QA technicians when necessary / Conduct tasks outlined in QA Tech-COA Coordinator, QA Tech-Raw Material Coordinator and QA Specialist job descriptionsQA Analyst (Ventura Foods)Thornton, IL - 2/1/2017 8/20/2018Perform Inspections including Pre-Operative and Food Safety document and communicate results.Perform Daily Operating Inspections as needed to assure compliance with GMP's and USDA requirements.Perform magnet and metal detector record check and inform Supervisor of deficiencies.Conduct ATP and Environmental swab testing.Calibrate Lab Scale, pH meters, salt analyzer, etcPreform in-bound raw and packaging material checks to ensure requirements are metFollows all Food Safety PPE/GMP requirements and reports any concerns in the plantPerform a variety of routine laboratory tests or other laboratory work to help provide top quality and safe products that meet customer requirements and specifications.Assist Plant operations personnel with quality and processing questions.Accurately test, monitor, and document quality results and processing data for products produced.Audit, verify and follow-up process controls such as weight checks, batch sheets, HACCP, plant inspections, receiving, etc.Support process variations as they relate to formula adjustments to satisfy customer requirements.Maintain a high and effective level of communication with all operating departments.Assure that all GMP, Sanitation, and housekeeping practices are being followed according to expectations.Utilize computer system for necessary quality functions.Maintain and complete files and documentation accurately and timely.Responsible for micro plating and recording results of finished product and maintaining mice logbooks.Conduct Sensory evaluation on finished product.General lab work such as maintaining QA retain storage room, disposing of old retains.Support to issue and solve internal corrective measures report.Ensure current product quality specification fulfill clients requirements.Support quality management systems operation within organization.Comply with all activities with corporate policies as well as departmental procedures to reduce risk and losses.Ensure program activities are in compliance with applicable government regulations and company quality assurance standards.Interact with superiors, team members and related people.Maintain temperature charts throughout the facility including changing charts weekly.Clean laboratory glassware and maintain lab housekeeping.Provide daily production support including testing, adjusting and disposition of start-up, in-process and finished product.Releasing of finished product.CONTRACT POSITIONS, 2015-2016ROBERT HALFOrland Park, IL - 08/10/2016 08/19/2016R&D Lab Project Assistant (RQA, Inc-Product Dynamics.)Responsibility for testing the product and recording the different results and being tech savvyKELLY SCIENTIFICKankakee, IL - 10/12/2015 11/13/2015Analytical Technician (DOW CHEMICAL)Executing sample analysis for manufacturing by utilizing various instruments and approved methods and specifications to certify their qualityUtilized SAP Business Solutions Software to input quality data and shipment needsResponsible for development and maintenance of laboratory documentsPerformed administrative tasksUtilized Good Laboratory PracticesRetention and disposition of expired raw materials and finished goodsCleaned and maintained instruments in clean and safe condition for future analysis usePrepared samples for analysis according to SOPInventory of reagentsSELECT SOURCE INTERNATIONALAbbott Park, IL -05/04/2025 05/13/2015Quality Assurance Project Specialist (ABBVIE)Reviewed executed batch record packets and associated documentationResponsible for visual inspection of line clearance/AQLCARDINAL HEALTHGlendale Heights, IL -02/2012 - 06/2014(P.E.T Radiopharmaceutical Manufacturing)Senior Specialist, Quality Assurance/SpecialistOversaw production operations to ensure each Positron Emission Tomography (PET) drug product meets safety requirements, has the identity and strength, and meets the quality and purity characteristicsPerformed technical review of the manufacturing batch records documentation for completeness and compliance with current good manufacturing practices (cGMP) as per regulatory requirements and internal proceduresSupported Good Manufacturing Practices (GMP) compliance and inspection readiness for the organizationPerformed and/or assisted with internal and external quality assurance auditsAssisted with coordination of work for Quality Assurance Operation team to facilitate timely release of drug product lotsParticipated in review and approval for investigations associated with deviations, corrective and preventative actions (CAPA), Environmental Discrepancy Reports and Alert Level ReportsProvided technical and quality operations support to respective departmentsApproved or rejected components, containers, closures, in-process materials, packaging materials, labeling, and products to ensure compliance with procedures and specificationsAdvised the Site Supervisor and Regional Quality Assurance Manager of any changes that may impact existing process validations, equipment qualifications or supplier qualificationsReviewed production records to see if errors were made during activities or to determine any product failuresAdvised the Site Supervisor and Regional Quality Assurance Manager of concerns that could impact the quality of the product or the success of the business, such as training needs, equipment problems, production data trends (yields, rejects, and failures), material changes and inconsistencies within the site and between sitesResponsible for overseeing that errors and product failures are fully investigated, documented and corrective actions are implementedPerformed other job-related duties as required, directed, and delegated by Quality Management to ensure the goals and objectives of the department are met.Worked within regulatory standards including Environmental Health & Safety (EHS), cGMP (current Good Manufacturing Practices), Radiation Safety, applicable FDA (Food and Drug Administration and pharmacy laws, DOT (Department of Transportation), and internal policies and interpretationsParticipated in weekly meeting on quality issuesPerformed quality assurance walk-through audits of laboratory areas to ensure compliance with cGMPs and company proceduresResponsible for reviewing and assembling batch documentation, issuing and tracking controlled documents, reviewing raw material documentation and releasing material, and calibration recordsPerforms other related duties as neededSupport corporate quality and continuous improvement processPrepared documents for External audits (FDA)THE SHERWIN WILLIAMS COMPANYChicago, IL -12/2001 07/2009Chemist II Conventional Coatings Industrial & Marine, R & DAssisted in the formulation, modification and production of High Temperature coatingServed on Safety Committee by Perform Safety/Housekeeping inspections in the laboratory and through site.Utilized Good Laboratory PracticesCleaned and maintained instruments in clean and safe condition for future analysis useChemist I - Industrial & Marine, R & DAssisted in the formulation, modification and production of ZERO VOC coatingsCreated and maintained for plants and lab a database used to adjust productsPerformed quality control testing and analysisTrained summer helpMaintained MSDS files; developed PowerPoint presentationsHigh speed batch mixingStability evaluationsFormula modificationOrder raw materials/supplies to keep work bench stockedLaboratory Tech & Laboratory Technician II - Industrial & Marine, R & DUsed ITM and ASTM standards for color acceptance and stability standards testing.Performed multiple projects small-scale shading. Used both visual and computer inspections to note any variations in hue, surface appearance or stability factors.Documented all test results in lab notebooks. Compared results from previous work. Archived lab notebooks.Assisted chemists with quality control testing. |
