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Online Resumes with "capa"
Engineer - 20 Years of Experience - Near 16505-1812
People oriented Engineer with twenty years experience in a Business environment using Lean Manufacturing, Kaizen, Six Sigma, and employing Safety Techniques, and Total Quality Engineering Management in an ISO 9001:2008 Lean Quality Environment. Worked within the Corrective Action Preventative Action (CAPA) System to reduce Supplier Escapes. Utilized the Continuous Improvement tools to improve Internal Processes. Resolved Fi...
Tags for this Online Resume: Manufacturing, Audit, Data Analysis, Product Design, Reliability, Quantify, Quality Assurance, Test, Transportation, Commodities
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Director of Quality - 20 Years of Experience - Near 28092
QUALIFICATIONS - OBJECTIVE STATEMENT Pragmatic, forthright and highly analytical Manufacturing Operations and Quality Assurance Professional with over 15 years successful experience overseeing process improvement, product quality, cost reduction, procedural efficiency and team development. Assesses end-user requirements and conducts root-cause analysis related to processes and operating inefficiencies. Recommends customized...
Tags for this Online Resume: Quality, Quality Assurance, Research and Development, Leadership, Manufacturing, Packaging, Training, 5S, Audit, Black belt, reliability, manufacturing, production, ISO-9000, TS-16949, Food-Safety, cGMP's, Technical Problem Solving Leadership, Shainin
Not Listed - 14 Years of Experience
Professional Qualifications "Foro de Calidad Regulatoria" (2014) * Training of Structured Problem Solving and Investigation Report Writing Effective Check, Caguas, PR (2014) * Training to Certify Quality Auditor (ASQ), Guaynabo, PR (2013) * "Mejorando tus Auditorķas Internas", Caguas, PR (2012) * Train the Trainer Certification, Caguas, PR (2012) * First Aid Certification, Caguas, PR 2012 - 2016 * CAPA Certification, Caguas...
Tags for this Online Resume: Chemistry, Hazardous Waste, Instrumentation, Millenium (Sw-Fin/Admin), Millennium, pH Meter, Quality, Quality Assurance, Quality Control, SAP
Quality Manager - 20 Years of Experience - Near 14225
COVER LETTER: Dear Madame or Sir: My talents in interpersonal communication, problem solving and team leadership should prove an excellent fit for your organization. With a high level of training across a variety of disciplines and extensive experience in providing an array of quality engineering and IT services to diverse manufacturing organizations, I am confident in my ability to immediately contribute to the success of ...
Tags for this Online Resume: ISO, Manufacturing, Aerospace, Etching, Management, Pc, Personal Computer, Xerox, Delphi, CAPA, CMM, FAI, PFMEA
Chemist - 20 Years of Experience - Near 12122
Profile: Experienced Analytical Chemist * Self-motivated, result driven, detail oriented individual, works well as a team member or independently, willingness to learn * Strong background in GMP/GLP, analytical and wet chemistry * Well-versed in USP, EP and JP policies and procedures, chemical hygiene and safety policies * Analysis and release of raw materials, finished products, in process, and stability samples * Method d...
Ideal Companies: Pfizer, GlaxosmithKline, Astrazenica
Tags for this Online Resume: Audit, Documentation, Kaizen, Management, Packaging, Quality, Quality Assurance, Quality Control, EP, pharmaceutical, Quality control, Laboratory, analytical, chemist, GMP
Production Supervisor - 13 Years of Experience - Near 48217
Areas of Expertise * Process Improvements * Overhead Reduction * Operations Leadership * Staff Training/Management * Safety/Regulatory Compliance * Technical Support * Program Oversight * Schedule/SOP Development * CAPA/NCRM Investigations Career Highlights/Achievements * Implemented process improvements for mixing area cleaning pumps, resulting in more than $400 cost savings on each of 10+ mixes done each week. * Developed...
Tags for this Online Resume: Packaging, Manufacturing, Protocol, Training, Scheduling, Audit, Integrate, Management, Process Improvements, Recruiting, manufacturing, reliability, production
Microbiologist - 10 Years of Experience - Across U.S.
Looking for a pharmaceutical, biotech or medical device role as a microbiology lead or team leader, or working in a remediation project involving environmental contamination or product testing. Also looking for a non-conformance owner position (deviation investigations).
Tags for this Online Resume: Compliance, Manufacturing, Packaging, Troubleshooting, Data Management, Management, Quality, Quality Assurance, Quality Control, Support, pharmaceutical, protocol, sas, Microbiology, Biopharma, contract, Environmental Monitoring, CAPA, Non-conformance, remediation, Microbial testing, Microbiology team leader, microbiology supervisor, parenteral, aseptic processing, ISO 14644
Quality Coordinator - 20 Years of Experience - Near 00705
Summary of Over 39 years of successful experience in Quality (Quality Assurance/Quality Qualification Control/Quality Operation) in the pharmaceutical and medical device manufacturing area. Strong knowledge of investigations and CAPA. Excellent knowledge in cGMPs, Incoming inspection, complaints handling, validations, change control, packing material, manufacturing and packaging area. Strong leadership, negotiation, communi...
Tags for this Online Resume: Filing, Management, Packaging, Audit, Injection Molding, Policies and Procedures, Quality, Quality Assurance, Quality Management, Medical, healthcare, Healthcare
Production Inspector - 20 Years of Experience - Near 98354
Summary: * Comes with an excellent experience of over 25 years as an Innovative Manufacturing Process Improvement Specialist / Engineer. * Proficient in selecting and designing assembly methods, design all assembly tooling, created and draft Work Instructions, create and maintain complete BOM including training of assembly personal. * Excellent track record of problem solving, by contributing to bottom-line results through ...
Tags for this Online Resume: Manufacturing, CNC, Fabrication, Lean Manufacturing, Quality, 5S, Aerospace, Packaging, Benefits, Capital Equipment, production, maintenance
Quality Supervisor - 18 Years of Experience - Near 11434
SUMMARY A professional Quality Control and Quality Assurance Engineer/Specialist with 9 years of experience implementing and improving quality management systems/ programs to support Manufacturing, instrumentation, Validation, and processes Quality Management Systems and Information Management Systems Qualification Summary: Quality Assurance (manufacturing) * Experienced in ISO 9001 and ISO 13485 standards to ensure that pr...
Tags for this Online Resume: Quality Assurance, Test, Database, ISO, Management, Manufacturing, Procurement, Quality, Quality Control, Quality Management, manufacturing, production
Quality Assurance Director - 20 Years of Experience - Near 33545
BSI ISO 13485:2003 Lead Auditor (TPECS) Certification - Certificate: 7930649-76913 * Hired and entrusted by B Braun McGaw of Puerto Rico and LeMaitre Vascular to implement a wide-array of corrective actions and systems resulting from 3 FDA warning letters. Subsequently after new systems implementation received 0 FDA 483 observations for a combined period of 12 years. * Built company-wide shared quality visions which complet...
Tags for this Online Resume: Documentation, Quality Assurance, Compliance, Pharmaceutical Industry, Quality, Quality Control, Regulatory Affairs, Medical Devices, Pharmaceuticals, Regulatory Compliance