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Online Resumes with "Process Validation "



Medical Device, Health Technology

Supplier Quality Management, ISO 13485 and supplier audits

Tags for this Online Resume: Supplier Quality Management, Certified Lean Leader, Certified Quality Engineer, Certified Master Black Belt, Certified Supplier Auditor, Certified Process Validation Expert

Chemical Plant System Operator - 15 Years of Experience - Near 60101

SUMMARY * Bachelor Degree in Science in Biology and has extensive years of laboratory experience. * Adherence to GMP, ISO Standards and OSHA procedures. * Performed PH, percent solids, conductivity, UV/Vis, Gel Electrophoresis, Carl fisher, fill weight as additional testing including simulation runs on the actual diagnostic instruments. * Knowledge / experience in Process Validation, Test Method Validation, Vendor Qualifica...

Tags for this Online Resume: lab tech , R, Safety, Tech Supp Lab Tech, word, Complaints, Distribution, Electrophoresis, Failure Analysis, OSHA, production, maintenance, manufacturing

Chemist - 20 Years of Experience - Near 84341

Areas of Expertise * Batch Record Review * Transfer of Analytical Data (TAP) * GMP & Regulatory Affairs * Remediation * Process Validation * Deviation Resolution * Lab Environmental * CAPA Investigation * Quality Compliance & Assurance * Product Quality Management * Manufacturing of Sterile and aseptic products * 21 CFR, EU Regulations, and ISO 13485 * Safety and Regulatory Compliance * HPLC for API and Finished Product usi...

Tags for this Online Resume: Manufacturing, Pharmaceutical, High Performance Liquid Chromatography (HPLC), Management, Pharmaceutical Industry, Research and Development, Regulatory Affairs, API, Application Program Interface

Quality Engineer - 20 Years of Experience - Near 32940

SUMMARY OF QUALIFICATIONS * I have over 25 years of experience in Quality Assurance. I served as the Procurement Quality Assurance management representative to the United Space Alliance Supply Chain Management Council. I have had direct responsibility to develop and maintain supplier management applications, data systems, policies and procedures and tools (audit, approval, process validation and certification, surveillance,...

Tags for this Online Resume: Metrics, Data Processing, ISO, Military Standard, Procurement, Quality Assurance, Rf, Audit, Assessments, Inspection Systems, Quality Engineer

Quality Control

SUMMARY OF QUALIFICATIONS Quality Systems - Quality Control /Quality Assurance Management of Analytical Laboratories/Quality Audits/Scientific Technical Services Liaison Highly motivated, key contributor in Quality Management and cGMP compliance with more than twenty five years of demonstrated growth and success in scientific applications with Contract Manufacturing Organizations in Quality, R&D and manufacturing. Recognize...

Tags for this Online Resume: Analytical Chemistry, Chemistry, Manufacturing, Research and Development, Commercial Production, Compliance, Packaging, Pharmaceutical, Documentation, Quality, validation, Audits

Developer - 8 Years of Experience - Near 30071

Summary: * 8 plus years of Java Development Experience that includes Analysis, Design, Development, documentation, Implementation, testing phases of Enterprise, Client/Server, Web based and system level applications in Java, J2EE, J2SE technologies. * Strong experience in SDLC with Waterfall, Iterative, Agile (Scrum) Methodologies (TDD) for Object Oriented applications and web based Enterprise Applications. * Expert in Test...

Tags for this Online Resume: Applications, Hibernate, HyperText Markup Language, Java Programming Language, Java Server Pages, JUnit, Servers, Data General Eclipse, Eclipse, Extensible Markup Language (XML), sql, java, javascript, c#, c++, agile, software, html, it jobs, linux

Clinical Quality Assurance - 20 Years of Experience - Near 46360

Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...

Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance

Not Listed - 5 Years of Experience

SUMMARY Resourceful professional with more than 15 years of outstanding customer service, administrative support leadership, and communication excellence. Dynamic, versatile professional with a proven track record for negotiation, mediation, and sales success. Reliable skills include client relations, staff development, and general office management. Recognized for working in high-stress, fast-paced environments driven by t...

Tags for this Online Resume: Administrative Support, Analytical Thinker, Appraisals, Customer Service, Desktop Computer, Documentation, Facilitator, Financial, Financial Statements, Insurance

JAVA full stack Developer

SUMMARY * 5+ years of experience in IT Industry as a Java/J2EE Developer involving in Analysis, Design and Testing of web based and client server multi-tier applications which use Java/J2EE technologies. * Experience in implementing OOPS concepts using Core Java, Groovy and Java/J2EE technologies such as Servlets, JSP, EJBs, JDBC, Spring, Struts, Hibernate and Web Services. * Well versed in all stages of Software Developmen...

Tags for this Online Resume: Application Server, Extensible Markup Language (XML), Java 2 Enterprise Edition (J2EE), Java Programming Language, JUnit, Servlets, Spring, Test, HyperText Markup Language, Information Technology, agile, software, html, javascript, it jobs, java, c#, sql, c++, linux

validation/quality/manufacturing engineer

PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...

Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing

Machine Operator

SUMMARY: A Graduate Mechanical Engineer with Master's degree in Mechanical Engineering and over 5 years of professional experience as a New Product Development Engineer and Manufacturing Engineer in the manufacturing field. Skilled in Sheet metal, Product Development, Feasibility study, Process validation, Root cause analysis, Lean techniques, FMEA, PPAP, APQP, CNC machines and other machining processes.

Tags for this Online Resume: MCAD Solidworks, Welding, Fabrication, Management, Manufacturing, Project Management, Value Engineering, APQP, CNC, Documentation

Microbiologist

A Validation Engineer with proven success working with major pharmaceutical companies and diversified experience across all aspects of the industry: Quality control manufacturing regulatory compliance and multiple departmental operations. Consistently demonstrating a high level of experience in all aspects of the development execution and close out of commissioning/qualification programs using process design documentation p...

Tags for this Online Resume: Manufacturing, Assessments, Automation, Utilities, Microbiology, Protocol, Collection, Documentation, High Performance Liquid Chromatography (HPLC), Marketing Management