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Online Resumes with "CAPAs"



Project Manager - 20 Years of Experience - Near 91302

SUMMARY OF QUALIFICATIONS Accomplished IT Sr. Project Manager and Product Manager with a broad background, over 20 years of experience in all phases of SDLC including the areas of Application Development, Implementation, Deployment, Project Management, Process Improvement, Computer System Validation and other positions of increasing technical responsibility. Knowledge of regulatory requirements and cGMP for computer systems...

Tags for this Online Resume: Database, Database Design, Integrate, Business Requirements, Javascript, BASIC Programming Language, FACETS, Hospital Information Systems, HyperText Markup Language, Legacy, Project Management, Agile, Scrum Master

Extractive Worker Manager - 15 Years of Experience - Near 2700

Summary I have over 10 years of work experience as Occupational Health, Safety and Environment Specialist with a passion for multi-tasking and safe operations, whilst investigating all incidents to determine root cause and implement corrective/preventative actions. Profile My activities have included: - ISO 14001/OHSAS 18001 Integrated Management Systems - Establishment, documentation and socialization/campaigns - Implement...

Tags for this Online Resume: JSA, Mining, Quality, Quality Assurance, Quality Control, Risk Assessment, Training, Management, Audit, Benefits, HSE

Quality Manager - 20 Years of Experience - Near 12534

SUMMARY OF QUALIFICATIONS: Over 25+ years experience in the field of Quality Assurance compliance in a wide variety of analytical laboratories and production settings. Specialization in regulated Quality Assurance manufacturing, compliance testing, packaging, labeling, and distribution of a variety of products.

Tags for this Online Resume: Auditing, Manufacturing, Quality Assurance, Technical Writing, Quality Control, Packaging, Testing, CAPA, Customer Complaints, Documentation, ISO 9001, ISO 13485, "project management"

Supply Chain Manager

Areas of Expertise ( International / Global Logistics ( Process Re-Engineering / SOX ( Financial / Budget Management ( Global Import / Export ( New Procedure Implementation ( Problem Identification / Solving ( Supply Chain Management ( Global Regulatory Compliance ( International Documentation ( Strategic Partnerships ( Best Practices / SOP Creation ( IT Acumen / Technical Knowledge ( Vendor Relations / Negotiations ( Team ...

Tags for this Online Resume: Distribution, Logistics, Purchasing, Compliance, ISO, Management, Manufacturing, Procurement, ISO 9001, Supply Chain, Import

Civil Engineer - 17 Years of Experience - Near 00638

SUMMARY OF ACCOMPLISHMENTS * Development, installation and verification support to projects related to facilities and utilities. * Development, installation and verification support to projects related to the Serialization of bottle packaging lines. * Installation and verification support to projects related with Packaging Lines. * Improvements to the Warehouse, Manufacturing and Packaging areas to achieve compliance with P...

Tags for this Online Resume: Consulting, Documentation, HVAC, Install, Instrumentation, Management, Manufacturing, Packaging, Project Closure, project engineer, project manager

Microbiologist - 20 Years of Experience - Near 07753

Summary I am a Scientist with twenty nine years of professional experience in the pharmaceutical, medical device, clinical and biotech industries. I have written SOPs, CAPA, audit reports, validation master plans, protocols, new product submissions and various other technical documents. I am very familiar with QSR, 21CFR211 and ISO standards: 13485, 14644 part 1 and part 2. I have used the five "whys" and fishbone methods f...

Tags for this Online Resume: Data Entry, Documentation, Root Cause Analysis, Technical Writing, Packaging, ISO, Pharmaceutical, Statistical Analysis, Audit, Management, pharmaceutical, sap

In Between - 20 Years of Experience - Near 95377

SUMMARY OF QUALIFICATIONS Benefits Administrator (Medical, 401K), Payroll (Manual, ADP WFN, Time & Attendance, Budgetrac), Recruiting Safety/Workmen's Comp, SB198, Training, Conflict Resolution, IIPP Department Budgeting, Office Management, Accounting, A/P, A/R Computer Literate (Microsoft Applications, Word, Excel, Lotus, Access, Outlook Internet, PowerPoint) Excellent Interpersonal & Communication Skills COBRA, FMLA, CFRA...

Tags for this Online Resume: Coaching, Insurance, Training, Payroll, Recruiting, Benefits, Accounting, Accounts Payable, Accounts Receivable, ADA

Production Manager - 20 Years of Experience - Near 00727

SUMMARY OF QUALIFICATIONS * Fully bilingual (English/Spanish) * 25 years of proven experience in the Manufacturing and Industrial Engineering field. * 24 years of Supervisory experience including exempt and hourly personnel in demanding manufacturing environments up to 125 employees. * Exposure to FDA, EHS, ISO certification and internal audits * Knowledgeable in the application and interpretation of labor laws, both federa...

Tags for this Online Resume: Compliance, Facilitator, Manufacturing, Process Improvement, Bilingual, English Language, Engineering, Industrial Engineering, manager

Quality Assurance Director - 20 Years of Experience - Near 92131

Summary Extensive strategic management development, deployment and execution supporting C-level, SVP and Sr. Management leading regulatory action remediation projects, coaching sponsors, key stakeholders and teams through containment, control, and compliance driving sustainability goals for Life Science companies in Biotechnology, Pharmaceuticals, Medical Device and Combination Products, addressing process improvement initi...

Tags for this Online Resume: Director Quality Assurance, Director Regulatory Affairs, Senior Project Manager, Director PMO, ISO, Software, Software Development, Quality Compliance, Director QARA

Quality Engineer

Summary To contribute my Engineering, Management, Client service, Computer Application, Continuous process improvement, quality management, and manufacturing operations expertise to a successful and growing organization. Expertise * Significant expertise with Continuous Improvement and Quality Tools, including Histograms, Pareto, Gantt Charts, and Flow Diagrams * Lean Manufacturing and Kaizen Event experience * Proficiency ...

Tags for this Online Resume: Quality Assurance, Training, 5S, CMM (Capability Maturity Model), Kaizen, R&R Report Writer, Data Analysis, Failure Analysis, Management, Root Cause Analysis

Quality Assurance Director - 3 Years of Experience - Near 94566

Walter holds a Master's Degree in Systems Management and a Bachelor's Degree in Industrial Engineering/ Quality Engineering. Walter is a Six Sigma Lean, Black Belt. He has extensive years of experience as Director and Senior Manager positions in Quality and Operations positions for Bio-Tech, Pharmaceutical and Medical Device industries. He has hands on experience in Project Management, Design Control Pre-Market, Post Market...

Tags for this Online Resume: Management, ISO, Compliance, Documentation, Risk Assessment, Audit, Manufacturing, Project Management, Project Manager, Risk Management, Quality Systems Professional

Featured Profile

Director of Quality & Regulatory- 22 Years of Experience - Near 45142

Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...

Ideal Companies: A company with suability, growth and development of their employees.

Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory