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Online Resumes with "c GMP"



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 and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, supplier management and all aspects...

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

Biochemist - 20 Years of Experience cGMP operations

Clinical Regulatory Affairs - 6 Years of Experience - Near 92648

QUALIFICATIONS Document-Labeling Specialist, Nov.2015 - Feb.2016 Well-versed communicator, high organizational and analytical (Contract Position Only) abilities. Work well independently and as a member of a * Creation, Revision of CGL, pre-printed labels and IFU via team. Adept in SUSARs, IRB submissions, Sponsor redlining documents and SOP standards. monitoring, and CTMS files. Efficient at handling multiple regulatory doc...

Tags for this Online Resume: R programming, Word, Excel, Adobe Photoshop, Illustrator, google analytics, github, Adobe, Data Entry, Documentation, ISO

Quality Assurance Director - 18 Years of Experience - Near 55379

Summary of qualifications Global Quality System and Regulatory Compliance Experience in Regulated Environments (Medical Device/Pharmaceutical/Food/In-Vitro Diagnostics) including implementation of design controls * Global Regulatory and Quality Compliance (creating processes for Field Actions/point of contact for all recalls with the FDA/806 and monthly reporting) * Regulatory partnering with FDA and International Agencies ...

Tags for this Online Resume: Documentation, Infrastructure, Management, Program Management, Budget Preparation, Budgeting, Development Activities, P&L, Product Development, Project Management

Analytical chemist - 15+ years eperience HPLC, LCMS; pharma-biotech

HPLC and LCMS method development and validation in support of small molecule drug discovery programs, reglatory submissions, or related area

Tags for this Online Resume: HPLC and UHPLC, LCMS and LCMS/MS, analytical chemistry, method development and validation, cGMP and GLP, regulatory submissions

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

Featured Profile

Production Supervisor/Validation Engineer - 7 Years of Experience - Near 29550

I am a highly motivated professional with 8 years expreience in the Pharmaceuticals manufacturing industry in supervision and validation. Expertise in writing and executing IOPQs, FATs, SATs, and production supervision. I am also proficient in troubleshooting packaging machinery and writing/revising SOPs. Currently I am working in the beverage industry with Coca Cola and gaining experience within the beverage and food indu...

Ideal Companies: Manufacturing

Tags for this Online Resume: Pharmaceuticals, Supervisor, Engineering, Automation, Packaging, Validation, Training, Leadership, Management, Manufacturing

Scientist

CAREER HIGHLIGHTS * Commercialized new pharmaceutical intermediates business valued at $200M in revenues, and drove $40M in revenues per year by commercializing 3 major new agrochemical opportunities with 2 European agrochemical producers. * COGS Reduction - As head of operations reduced cost of goods sold by 20% during 2-year period by focusing on all aspects of process control and implementing Lean manufacturing methodolo...

Tags for this Online Resume: Focus, Consumer Electronics, Electronics, Engineering, Pharmaceutical Industry, Process Engineering, Quality, Telecommunications, Transportation, Manufacturing

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

Manager - 10 Years of Experience - Near 01583

Tags for this Online Resume: Asset Management, Distribution, Due Diligence, Layout, Logistics, Management, Oracle, Packaging, Quality, Quality Assurance, SAP, DOT, fmcsa, cGMP, ISO, manager, 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

Director of Quality - 20 Years of Experience - Near 91709

SUMMARY OF QUALIFICATIONS * Over twenty years of experience managing regulatory affairs (RA)/quality assurance (QA), quality control (QC)/research & development (R&D) departments in pharmaceutical, medical device and dietary supplement manufacturing industries. Implemented Quality Management Systems meeting domestic and international regulatory requirements and ISO registration. Reviewed pre-clinical, clinical and pharmacok...

Ideal Companies: Pharmaceutical, Medical Device, Biomedical

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Microbiological Testing, Test, ISO, Pharmaceutical, ADA