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Online Resumes with "CGMP"
Production Supervisor - 0 Years of Experience
HIGHLIGHTS OF QUALIFICATIONS 1. Many years of pharmaceutical leadership experience in a Biotech and parenteral drug-manufacturing environment. 2. Diversified experience in sterile manufacturing including bulk manufacturing, aseptic filling, component sterilization, freeze drying, environmental monitoring, inspection and packaging. 3. Knowledge of governmental cGMP, OSHA, DEA regulations and procedures, experience with FDA, ...
Tags for this Online Resume: Packaging, Inventory, Manufacturing, High Performance Liquid Chromatography (HPLC), Leadership, Monitoring, pH Meter, Spectrophotometer, Labor Relations, Occupational Safety and Health Act
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
Department Manager - 20 Years of Experience - Near 00693
Professional validation expert and scientist with up to thirty years of overall experience in the Pharmaceutical Medical Device and Biotechnology Industry. Proficient in manufacturing industry environment including but not limited to facilities utilities solid dosage equipment HVAC water systems chemical plant equipment chemical biotechnology and microbiology instrumentation handling validation (IQ OQ PQ) validation plans c...
Tags for this Online Resume: Quality, Quality Assurance, Project Leader, Project Management, Support, Manufacturing, Test, High Performance Liquid Chromatography (HPLC), Injection Molding, Instrumentation
Quality Engineer
SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.
Tags for this Online Resume: Packaging, Manufacturing, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Quality Control, Training
Biochemist
Summary of Qualifications Senior level molecular biologist with extensive experience 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, RNA isolation from tissue samples and ELISA. Familiar with cDNA synthesis and primer ...
Tags for this Online Resume: Data Analysis, Documentation, Good Laboratory Practices, Good Manufacturing Practices, ISO, Layout, Manufacturing, Software, Typing, Construct (App Dev Tool)
SENIOR PERSONAL CARE PRODUCTS CHEMIST WITH 15 YEARS OF EXPERIENCE IN FORMULATION, TESTING, AND REGULATORY STANDARDS
Applying my Education and Experience in Every Possible Way to achieve the Maximum Profitability and lowest Cost Possible to the Employer
Ideal Companies: Johnson and Johnson, Proctor and Gamble, Unilever, Colgate - Palmolive
Tags for this Online Resume: ANSI, Ansi (Am Natl Stds Inst), OTC, Quality, Chemist, Formula, Personal Care, Cosmetics, Household, QC, R & D, FDA, Consult
Pharmaceutical Scientist
ver fifteen years of solid experience in pharmaceutical Quality Assurance, Quality Control, Stability, Analytical methods development, Validation, Instrumentation, Lab supervisor and Academic. Accomplished, results-oriented individual with expertise in pharmaceutical area. Extensive hands on experience with HPLC, TLC, GC, TGA, UV/VIS, FTIR, IR, AA, Fluorescence Spectrophotometer and Dissolution. Up-to-date knowledge of cGM...
Ideal Companies: J&J, Celgene, Merck
Tags for this Online Resume: Scientist
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
Clinical Quality Assurance - 0 Years of Experience
Executive Profile Summary I have for over 25 years acquired a vast knowledge in cGMP, Quality Management Systems, and Quality & Compliance in the areas of Pharmaceutical / Biotechnology / Biologics / Chemical Product Development / Quality Assurance & Control, and Food and Chemical Industries (which includes Food & Consumer Goods), (Industrial Retail & General Manufacturing ). My detail-oriented critical thinking creative-pr...
Tags for this Online Resume: Quality, Quality Assurance, Management, Test, Consulting, Engineering, Pharmaceutical, Protocol, QA/QC, Acquired Immune Deficiency Syndrome (AIDS)
Analytical Chemist
● Utilizes broad technical knowledge and troubleshooting skills to perform testing of a various biological matrices ● Utilizes Labnotes, Watson for transferring the samples and data ● Experiences in current Good Manufacturing Practice (cGMP), current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), requirements and Health Author...
Ideal Companies: Pharmaceutical
Tags for this Online Resume: Manufacturing, High Performance Liquid Chromatography (HPLC), Teamwork, Troubleshooting, Research, Instrumentation, Chemistry, HYGIENE, Millenium (Sw-Fin/Admin), Millennium
Laboratory Technician - 0 Years of Experience
* Biologist with experience testing clinical trials in a global clinical immunology department * Concentration in routine analysis of human sera samples using assays such as: ELISA, PRNT, and HAI * Demonstrated professional appearance and manner, excellent communication skills, and ability to adapt quickly to a challenge and complete assignments * Maintained notebook and logbooks in adherence to cGMP standards * Practiced ...
Tags for this Online Resume: Clinical Research, Research, Test, ELISA, Audit, Communication Skills, Electrophoresis, Excellent Communication Skills, Immunology, Internal Auditor
Clinical Quality Assurance - 13 Years of Experience - Near 53144
SUMMARY of QUALIFICATIONS Results driven Regulatory and Quality Assurance Management Professional with 12 years Medical Device and Pharmaceutical industry experience. Proven expertise in Quality Systems, Regulatory Compliance, Supplier Quality, Product Manufacturing, Design Control, and Data Systems. Natural leader that enjoys Continuous Improvement and fostering a culture of teamwork by empowering staff to achieve collecti...
Ideal Companies: FK
Tags for this Online Resume: Compliance, Product Development, Quality Assurance, Manufacturing, Audit, Instrumentation, ISO, Management, Medical, Pharmaceutical, device, fda, Regulatory
