CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "cGMP"

Chemist - 20 Years of Experience - Near 95127

SUMMARY Performed work in compliance with EPA, ISO, cGMP and GLP regulations and SOP's. Conducted chemical analysis using various analytical instrumentation and measurements. Supported production and research providing fast, friendly service. Maintained inventory of chemicals for department and ensured that it was clean and safe work area. Monitored hazardous waste container and had container remove as necessary. Experience...

Tags for this Online Resume: Benefits, Accounting, Administrative Assistant, Attention to Detail, Certificate Authority, Chemistry, Compliance, Good Laboratory Practices, Hazardous Waste, High Performance Liquid Chromatography (HPLC)

Chemical Engineer

PROFILE project management and handling instruments/equipment * Good understanding of various chemical processes (Distillation, Heat Transfer, Fluid Mechanics, Chemical Reaction Kinetics) * Excellent knowledge in ISO Standards, FDA guidelines 21 CFR Part 11, Part 210, Part 211, SOP, cGMP, cGLP, Audit trails, GAP Analysis * Familiar with safety protocols followed in research labs and worked on projects/assignments related to...

Tags for this Online Resume: Statistical Analysis, Audit, Autocad, Autodesk AutoCAD, C Programming Language, CFR Part 11, Corrective Actions, Green Belt, HAZOP, HTTPs

Facilities Manager

AREAS OF EXPERTISE: Wide range of expertise in project engineering, construction management, third party facilities management, high rise real estate, maintenance management, plant operations, engineering, design and project management of ventures ranging from $50,000 to $760 million dollars. Facilities Engineering and Design Consultants (F.E.D.C.) Facility Management, Project Engineering, Design & Property Management Compa...

Tags for this Online Resume: Autocad, Autocad 3D, Autodesk AutoCAD, Budgeting, Cancer, Cobra, Cogeneration, Construction, Consumer Products, epa

Quality Manager - 15 Years of Experience - Near 54220

PROFESSIONAL SUMMARY: Food Safety Specialist experienced in Production Supervision, CI, Food Safety and Quality Assurance. In-depth knowledge of Quality Management, 1st and 3rd party Audits, OSHA Standards, cGMP regulations, FDA, HACCP and SQF requirements

Tags for this Online Resume: OSHA, Packaging, Audit, Control Systems, Corrective Actions, Quality, Quality Assurance, Quality Control, Root Cause Analysis, Compliance

Biological Technician - 3 Years of Experience - Near 94303

Summary: Experienced commissioning engineer with over 12 years of practical experience in biotech. Proficient with most equipment related to cell culture fermentation, and oral solid dose pharmaceutical manufacturing facilities. Very strong in GMP documentation FDA, ISO 9000, cGMP, CFR title 21 and DEA regulatory compliance. Familiar with LIMS, BMS, Trackwise, Faciliworks, Word, and Excel.

Tags for this Online Resume: Documentation, Automation, Honeywell, Schematics, Pharmaceutical, Science, BMS, Compliance, Good Manufacturing Practices, ISO, Validation

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

Technical Writer, Philadelphia metro, NYC, Connecticut, New Jersey

I am equipped with 25+ years of experience in Documentation Design/Development and Technical Writing. I am currently exploring gainful opportunity prospects in Pharma and Bio Research. * Analytical and detail-oriented Technical Writer, with vast experience in technical documentation development across various industries. Strong background in writing with superb written communication skills. Expert knowledge in document life...

Tags for this Online Resume: Documentation, Manufacturing, Validation, Technical Writer, Microsoft Excell, Change Control, Microsoft Office, Microsoft Visio Professional, Microsoft Word, GMP

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

Biologist

Summary of Qualifications Senior level molecular biologist experienced in research and manufacturing environments. * Proficient in a variety of molecular biology techniques - Small and large volume Nucleic acid extraction (Miniprep), DNA quantification (BioAnalyzer, Nanodrop), NGS sample preparation (Ion Torrent PGM), PCR/qPCR. Experienced with liquid handlers, automated systems and data analysis (Excel). Fast learner and v...

Tags for this Online Resume: Data Analysis, Documentation, Good Laboratory Practices, Good Manufacturing Practices, ISO, QPCR, Manufacturing, Research, Experimental Design, Construct (App Dev Tool), Problem Solving skills

Production Manager - 157Years of Experience - Near 08723

SUMMARY * B.S. Biochemistry + M.B.A. Pharmaceutical Management with over 17 years of pharmaceutical industry experience * 12 Years of Parenteral Manufacturing experience. Member of PDA. Attended Courses at University Tennessee * 13 years of production experience in an FDA regulated environment such as Biopharma, OTC, medical devices in clinical, commercial drugs, consumer products, and nutraceuticals. * 11 years of producti...

Tags for this Online Resume: Forecasting, Medical, Project Management, Project Manager, Scheduling, 5S, Engineering, Kaizen, Outsourcing, SAP, production, manufacturing, reliability, "project management", Clinical drug supply, Packaging and labeling, GMP andGCP, SOP, 21CFR11

Scientist - 5 Years of Experience - Near 08830

PROFESSIONAL SUMMARY * Experience in design and development of variety of dosage form semi-solid (cream, lotion, gel, ointment), liquid (solution, suspension) and nasal spray. * Experienced in preformulation, characterization and formulation optimization using solubility, skin diffusion, in-vitro diffusion, viscosity, yield stress, pH etc. * Designed Quality Target Product Profile (QTPP) and identified Quality Attributes (Q...

Tags for this Online Resume: Manufacturing, Quality of Service, Distribution, SEMI, Assessments, Centrifuge, Development Activities, DSC, Good Laboratory Practices, High Performance Liquid Chromatography (HPLC), pharmaceutical, research

Production Supervisor - 7 Years of Experience - Near 64504

QUALIFICATIONS * Proactive and results-oriented pharmaceutical manufacturing and production supervisor with 14+ years of experience overseeing all teams and operations to ensure accuracy, quality, and safety within high-volume, challenging pharmaceutical manufacturing. * Efficient prioritizing, organizing and multi-tasking skills developing process improvements, implementing new procedures, focusing on safety, and implement...

Tags for this Online Resume: Scheduling, Reviews, Training, Management, pH Meter, Spectrophotometer, Corrective Actions, Inventory, Manufacturing, SAP