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Click here or scroll down to respond to this candidateCandidate's Name 245 Baccharis Drive Columbia, SC 29229 (C) PHONE NUMBER AVAILABLE EMAIL AVAILABLE PROFESSIONAL SUMMARY Highly talented professional with years of experience in Quality Assurance Operations. Strategic visionary able to crystallize and communicate the vision and goals of the organization. Well versed in all aspects of ISO 9000, Safety, team dynamics, and Production analysis. Skilled in the practice of Process Improvement, Quality Assurance, Root Cause Analysis and other Quality initiatives. Experienced in budgeting, accounting principles and overall operations. Additional Strengths and Competencies include: Inspection Quality Reporting Document Control Audit Leadership Effectiveness Process Improvement Production Analysis HACCP Product InformationManagement System Creating SOP's X-Rite Critical Problem Solving cGMP SAP Pantone Batch Record Review Caliper Aseptic Sampling Customer Relations GFSI Gas Chromatograph FTIR Creating Test Plans Tensile Tester Aseptic training CAREER HISTORYNephron Pharmaceuticals West Columbia, SCQuality Operations Material Management Lead Specialist 2015-PresentPrimary Accountabilities Receiving and dispositioning active and excipient raw materials Creating folders for raw materials received D.E.A. and FDA clearance to receive and sample controlled substance raw materials Samples and releases commercial use raw materials Reviews manufacturers documentation prior to receiving raw materials and production components Reviews Chemistry and Microbiology Lab results to ensure that results meet established specifications Request Conformance of Analysis from Batch Record Review Department to place in folder that houses all components/raw materials documentation to validate components/raw materials meet established specifications Processes production components, raw materials/controlled substances and corresponding documentation provided by warehouse Collects samples for incoming inspection based on MIL-STD 105E/ ANSI/ASQ Z1.4 Performs the incoming inspection as necessary using current procedures, measurement equipment, drawings/proofs and other elements Documents, reviews and completes all required paperwork (Raw material/controlled substances or Production Component Folders) to release or reject the production components, raw materials and related corresponding documentation based on inspection results Processes R & D and Compounding raw materials and production components, reviews, approves and dispositions material Creates and amends new and current SOPs respectively Use of Proofs/drawings to validate production components received for production use. Sampling raw materials in cleanroom/aseptic environment. Sampling and dispositioning of resin. Training in Aseptic Sampling and Testing.Quality Line Technician 2015 2015Primary Accountabilities Monitors and perform start up, in-process and finished product inspections including weighing. Maintain quality assurance documentation. Promotes teamwork both within the QA Team and other departments. Monitor all production areas and personnel for adherence to all cGMP, SOPs and safety regulations. Keep line and work station clean and orderly. Verify incoming packaging materials, raw materials, in process and finished products. Ensure that there is no product line contamination. Perform line clearance including equipments, components and label verification. Inspect and release machines and processing rooms for production. Support validation and manufacturing studies including special sampling and testing. Organize workload during lot and batch changeovers for efficient execution. Review and approve production batch records for release into production. Release finished product for packaging. Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor. Review all completed production batch record documentation to ensure completion and compliance. Investigates out of range percentages.Aryzta, West Columbia, SCQuality Line Technician 2014-2015 Conducts finished good evaluations Physical, Sensory, Analytical and Comparative Record evaluation results associated with finished goods Retain and maintain finished goods and raw material samples Review and validate supplier raw material records and evaluation results at the time of receipt Report and react to any non-conformance, abnormal observation or notifications as they occur. Conduct daily GMP, and process audits. Monitor and record HACCP, CCP records Monitor finished good weights to ensure compliance with regulatory standards Accurately complete required forms / checklists Enter data into computers using standard office software. Calibrates evaluation equipment including thermometers and viscometers Ensure a clean and safe working environment. Assist and participate in QA projects and QA team objectives Supports the Manufacturing, Distribution, Sanitation, Maintenance, Development and Administration staffs as appropriate. Knowledge of HACCP, cGMP and GFSIConstantia-Hueck Foils, Blythewood, SC 2006-2012Lead Laboratory Technician II Responsible for high quality inspections on high performance flexible packaging material. Responsible for preparation of non-conforming materials reports for suppliers Generated customer documentation as required for accuracy and product release Prepared internal Standard of Performance and Training documentation Responsible for analyzation and reporting of laboratory trends Responsible for quality assurance report preparation and distribution Responsible for coordination of calibration and maintenance of laboratory equipment Perform prescribed maintenance checks on equipment Responsible for Inventory management including laboratory and requisition supplies, work in process and quarantine materials. Prepared training materials pertaining to ISO, SQF, etc and facilitated training classes for all production employees. Conducted annual procedural training as well as all CGMP new hire training for Production area Responsible for quality, safety and efficiency of laboratory Provided support for external audits Responsible for review of batch records Collaborated with R & D team to develop new products and cost saving product improvements Eastman Kodak Company, Rochester, NY 1992-2006Senior Operations and Lab Examiner Responsible for inspection of imaging products per customer specification and satisfaction Oversee product conformance to standards and destinations worldwide Responsible for managing customer dissatisfaction and resolution Responsible for creation of continuous improvement processes to meet customer demands Interaction with technical and engineering Departments to regarding production status and to ensure, down line and upstream operations efficiency.Material Handling Responsible for shipping and receiving, inventory control Electronically ordering material and supplying for downstream customers Data entry and material tracking Computing location of inventory Daily meeting with engineers and management to discuss operational needs, concerns and improvement opportunities. Loading/unloading trailers using standup or sit-down fork trucks Transporting material and scanning it in to location Inventory Control by comparing electronic printout verses whats in the physical location/floor EDUCATION/PROFESSIONAL DEVELOPMENT/CERTIFICATIONSPolitical Science - Geneseo State UniversityCertifications-Auditor (ISO9000) SQF Practitioner Trainer Training - Managing Employee Safety and Health, cGMP trainer, Electrical AwarenessLeadership in DiversityThe Control of Hazardous Energy (1910.147)Hazard Communication (1910.1200)Bloodborne Pathogens (1910.1030)Blood/Body/Fluid Clean Up (1910.1030)Respiratory Protection (1910.134)Combustible Dust Hazard (1910.242 & NFPA654)Compressed Air Safety (1910.242)HACCPcGMPGFSIInstruments |
