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Hands on Experience in cGMP, GLP and FDA Regulatory Compliance, Blood and Plasma Processing and Laboratory Method Validation - Technical Consultant #886

Senior consultant in pharmaceutical and medical devices with emphasis in blood testingPharmaceutical and biotechnology quality assurance and control (QA, QC.)Regulatory compliance, consent decree and FDA batch record reviews-investigations; European audits.Plasma and blood collection centers and computerized donor record files.Blood and plasma quality assurance and control.Pharmaceutical QC methods development and review.Pharmaceutical validation of laboratory methods.Quality systems, quality control laboratory and development of standard operating procedures.Regulatory compliance audits; quality system audits.Vaccine stability, raw materi...

SAP and ERP Consultant for Pharmaceutical Manufacturing - Technical Consultant #1057

Pharmaceutical Quality Systems Implementation, Training and Audit ConsultantForty years of pharmaceutical and biotech industry experience - Production and development environments.Validation (computerized systems, equipment, processes), pre-acquisition - due diligence, quality assurance, compliance, quality control, research and development, technology transfer and clinical operations.Small and large molecule and vaccines, (Flu, Anthrax, and Rabies).International and domestic experience and assignments, (Europe, China and India).Exit strategy development, tracking and adjustment.Working with small, medium and large firms, assisting and man...

Pharmaceutical Laboratory Analytical Chemist: QA/QC, Validation and FDA - Technical Consultant #1166

Experienced pharmaceutical laboratory manager and analytical chemist with expertise in GLP and GMP compliance and solid dosage forms.Extensive experience in pharmaceutical, nutraceutical and chemical industry analytical laboratories.Laboratory management and analytical laboratory improvement, cGMP and GLP compliance and problem resolution.Pharmaceutical process, cleaning and analytical methods validation.Solid dosage for OTC drug products.Responsibility for QA/QC functions for testing, complaint handling, customer audits and data analysis for over 300 different drug products.Training on cGMP and GLP compliance and problem resolution.Docume...

High Protein Low Carbohydrate Foods and Beverages Manufacturing Formulation Expert - Technical Consultant #1222

Expert manufacturer of high protein low carbohydrate foods and beverages including soy isolate, high energy bars and beverages, fish protein, whey protein, infused fruits and vegetablesManufacture of high protein low carbohydrate bar formulations.Production of high energy and sport beverages; fruit and vegetable juice processing.Facility startup for sugar replacement blends; infused fruits and vegetables, soy isolate, fish protein concentrates, whey protein concentrates.Food product formulation, herbal extraction, food dehydration.Quality Assurance and SOP's for food and dairy products.Food industry membrane processing.

Expert for manufacture of glycolic acid and esters and handling of hazardous chemicals such a phosgene, anhydrous ammonia, methylamines, sulfur trioxide and dimethylsulfate. - Technical Consultant #1226

Expert for manufacture of glycolic acid and esters and handling of hazardous chemicals such as phosgene, anhydrous ammonia, methylamines, sulfur trioxide and dimethylsulfate.Registered Professional Engineer in West Virginia, Ohio and Pennsylvania.High pressure chemical processes (over 500 atmospheres) for both glycolic acid gaseous and liquid applications.Use of exotic materials of construction in difficult process conditions, e.g. titanium and silver.Glycolic acid production and the esterification of glycolic acid.Decolorization and ion exchange for chemical processing.Handling of highly hazardous chemicals, e.g. phosgene, anhydrous ammon...

Organic chemist expert in polycarbonate manufacture, polycarbonate formulation and plastic compounding, blends, properties and application - Technical Consultant #1246

Organic chemist expert on polycarbonate resin manufacture, quality, formulation, blending, compounding, grades and applications.Polycarbonate product developments for specific application needs.Troubleshooting on polycarbonate production problems.Knowledge of the plastics additive suppliers and polycarbonate raw material suppliers.Polycarbonate manufacturing from pilot scale to plant scale.Recovery of catalysts for better economics and to comply with EPA regulations.Developed polycarbonate blends, PC/ABS, PC/polyester, to suit market needs.Led global team to harmonize the additives for the polycarbonate product line.Polypropylene products,...

Technical operations consultant on sterile packaging, electronic materials, injection molding, elastomeric resin compounding, and composites - Technical Consultant #1251

Technical operations consultant on sterile packaging, electronic materials, injection molding, elastomeric resin compounding and compositesSterile packaging, design, production and testing of medical devices.Microbial film barrier of porous materials.Electronic printed circuit board production and assembly.Electronic PCB failure analysis and process troubleshooting.Organic matrix composite material production and troubleshooting.Injection molding of thermoset and thermoplastic resins.Compounding of high performance elastomeric resins.Material selection/optimization for harsh environments.

Project Manager and Consultant for Sterile Medical Device Manufacturing, Process Startup, and Quality Improvement. Develops long range facility utilization and expansion plans. Project management, operations management, and product design. - Technical Consultant #1425

Consultant skilled in project management, operations management, and quality management with emphasis on medical device manufacturing, sterile products, and designs for manufacturing. Special expertise in medical devices of cutting blades and surgical tools.Manufacturing process startup, integration, improvement and relocation.Project management, operations management and quality management with emphasis on medical device manufacturing.Engineering and product design for manufacturing.Manufacturing of sterile products on a global basis.Production process startup, integration, improvement and geographical relocation.Project management, oper...

Pharmaceutical Consultant for Dosage Form Manufacturing, Packaging, Quality Control and Validation - Technical Consultant #1434

Over 15 years experience in pharmaceutical manufacturing of solid dose, liquid/semi - solids, and transdermal products.Expert in solid oral, liquids and transdermal pharmaceutical dosage forms.15 years of pharmaceutical Quality Assurance, research and development and commercial manufacturing experience.Process expertise in development and manufacture of solids, liquid and transdermal dosage forms.Supply chain experience in warehouse and distribution operations, including design and operation of Automated Storage and Retrieval Systems (AS/RS).Technical expertise in qualification of equipment, utilities and facilities, cleaning and process v...

Validation Consultant for Medical Devices - Technical Consultant #1588

Consultant for Medical device FDA/ ISO Regulatory Compliance.Medical device FDA/ ISO regulatory compliance.Design control systems, both hardware and software, for medical devicesRisk analysis, vendor qualifications and documentation related to medical devices.Software and process validations.Design and manufacturing engineering in flowmeters.Contract Manufacturer Organization (CMO) selection and qualification for medical devices.Drawing and document control systems, configuration and management.Human factors programs.Component acceptance procedures/ non conforming product disposition.Audits, gap analysis and response to FDA 483 forms and w...