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Online Resumes with "21CFR"



Programmer Analyst

SUMMARY * 6 years of experience as a Statistical Programmer in Clinical trials of Pharma Industry. * Expertise in SAS programming features like BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, and ODS. * Skilled in generating reports featuring various SAS procedures, like Proc Report, Proc Summary, Proc Freq, Proc Mean, Proc Transpose, Proc sort, Proc Univariate, Proc Datasets, Proc Compare, Prco SGPLOT, and Proc SQL. * ...

Tags for this Online Resume: Base SAS, Macro (Predefined Code), Proc, SAS, SAS/STAT, Statistical Analysis, Structured Query Language, Data Analysis, HyperText Markup Language, Microsoft Excel

Chemist - 8 Years of Experience - Near 08855

SUMMARY: * Over 16yrs pharmaceutical experience in Quality Control, Stability and R&D, Drug development & approval, sterile injectable pharmaceutical manufacturing, solid dosage manufacturing, aseptic techniques, and clinical packaging/ labeling for top pharmaceutical companies. * Solid background in Instrumental Analysis and GMP compliance. Expertise in hands-on use of instrumentation such ICP, GC/MS, HPLC, LC/MS, UV, and ...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Research, SEC, Securities and Exchange Commission (SEC), Support, Instrumentation, Audit, Good Laboratory Practices, Good Manufacturing Practices, oncology, phase, protocol, pharmaceutical, clinical

Director of Quality

Summary Dedicated professional with 20+ years' experience in Integrated Management Systems, including Quality (ISO 9001), Environmental (ISO 14001), and Health & Safety (OHSAS 18001) with 12+ of those years as Head of Quality Management in different industries. Broad experience in MS-Office, MS-Visio, Project Management (MS-Project) and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, Supplier Management a...

Tags for this Online Resume: R&R Report Writer, Automotive, Management, Quality, Quality Assurance, Quality Management, ISO, ISO 9001, Documentation, Project Management

Production Supervisor

Summary Manufacturing Professional - Solid experience directing and supporting multi-shift, cGMP/QSR production operations for medical device product lines in an FDA registered facility. Managed team of 60 employees and 3 supervisors. Responsible for compliance with FDA 21 CFR Part 820 and ISO13485 regulations. Character - a strong work ethic of integrity and honesty with perfect attendance Additional Qualifications High pu...

Tags for this Online Resume: manufacturing, reliability, production, Lean Manufacturing, Packaging, Disaster Recovery, Inventory, Sales, Allergy, Pharmaceutical

Quality Coordinator - 5 Years of Experience - Near 08817

PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...

Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting

Network Engineer - 13 Years of Experience - Near 23188

Experienced with MSP applications such as Connect Wise and Kaseya providing comprehensive IT support to small and medium size businesses. * Palantir. O365 Migration Consultant, Palo Alto, CA 4/17 - 7/17 Created documentation to minimize foreseeing users' migration disruptions. Ei, Distribution list, Rooms, Transport Rules etc Worked with Power shell to create Bulk users, Distribution lists, O365 Groups, and place mailboxes ...

Tags for this Online Resume: Active Directory, Applications, Blackberry, CFR Part 11, Cisco, Cisco Switches, Database, Database Applications, Dell, Desk Top Support, Netwrok Engineer

Business Analyst

Qualifications Summary * Over Twenty years' technical writing experience in an enterprise delivery setting. Expertise with end-to-end SDLC/ITIL software development process industries I've worked in include: Electric Utilities, Financial Services, Mining, Food and Beverage, Food and Produce Distribution, Health Imaging, Manufacturing, Oil and Gas, Pharmaceutical IT, Retail and Media Relations * Develop both classroom and we...

Tags for this Online Resume: Documentation, Lightweight Directory Access Protocol, Research, Research and Development, Risk Analysis, Script, Technical Documentation, Test, Test Script, Technical Writing

Principal Engineer

ACCOMPLISHMENTS * Project management of Medical Device right from conceptualisation to manufacture in an ISO/FDA regulated environment. Used suitable stage gates and milestone list to inform key stakeholders about progress of the project. * Planned the project budget, schedule and used change control procedures for controlling changes and preventing scope creep. Negotiated with functional managers for resource allocation an...

Tags for this Online Resume: Medical, Medical Devices, Engineering, Instrumentation, ISO, Management, Cancer, Documentation, Manufacturing, NPI

Documentation Associaye 17 years Experience in Pharmaceutical industry

CAREER SUMMARY Quality Assurance Professional with experience in pharmaceutical manufacturing enforcing quality standards in a manufacturing unit. Skilled at studying industry and consumer requirements, running tests, writing quality assurance procedures, preparing quality reports, and assigning quality assurance tasks to employees. Proficient interacting with various departments including Supply Chain, Production, MS&T, Va...

Tags for this Online Resume: Documentum, Documentum (Wkflow Sw), Supply Chain, Change Control, Compliance, Corrective Actions, Documentation, Folder, Forecast, Management

Medical Transcriptionist

Areas of Expertise * Leveraging 510 (K) PMA and expertise in US, EU, TGA and Canadian medical device regulations. * Manage Kosher/Halal records for ingredients and resale products prepare kosher/Halal applications and registration for products and manufacturing facility. * Knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807). * Knowledge of ISO 13485, ISO 14971, ISO 9001 and work...

Tags for this Online Resume: Manufacturing, Regulatory Affairs, Test, Advertising, Due Diligence, ISO, Quality Assurance, Compliance, Quality, Quality Control

Featured Profile

Quality Assurance Engineer - QSR/ISO13485 - Validation

To work for a Medical Device company where my experience and skills in Quality Assurance and Validation can be put to good use. What I value most in my career: 1) Personal confidence that I can do the job/task. 2) Upper management confidence that I can do the job/task. 3) Satisfaction that the career/job I’m doing is worthwhile and benefits others. 4) People important in my life recognize value in what I do and that I ...

Ideal Companies: Roche, Johnson&Johnson, Genentech, Eli Lilly

Tags for this Online Resume: Quality Assurance, Medical Device, Validation, ISO 13485 Auditor, TrackWise, Validation - Process, Equipment, ISO 13485 Compliance Auditor, Risk Management, ISO, ISO 9001

Featured Profile

Director of Quality - 24 Years of Experience - Near 11801

Professional Summary Highly effective professional offering 30 years of US global quality leadership experience developing strategies, improvement action plan and solutions. Dedicated leader to bring organizations together, focusing on hi performance culture leading to improvement and efficiency. Built fully engaged team that is motivated to achieve metrics and deliver ROI. Lead and empowered cross functional teams to impro...

Ideal Companies: end of the year 449.00 + 4 months of our service. resume rewtire and cover letter.

Tags for this Online Resume: TQM (Total Quality Management), Manufacturing, Assessments, Audit, Quality, Quality Management System, HACCP, Continuous Improvement, PCQI, Supplier site and internal audits, USDA, FDA, ISO 9001, SQF, BRC, ISO 22000, ERP, OOS, Investigation, CAPA, NCR