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Online Resumes with "GLP "



Biologist - 20 Years of Experience - Near 94806

Career Summary * Lab Manager with over 25 years of optimizing efficiencies. * Able to coordinate initiatives (both scientific and administrative) within research laboratories strives to propel professionalism while minimizing the efforts produced within the workplace. * Adept at supporting and collaborating with other team members to implement the most appropriate policies, procedures, and protocols for assignments. AREAS O...

Tags for this Online Resume: Administrative Assistant, Critical Care - Neurology, Neurology, Research, Radiation, Complaints, Water Supply, Adobe, Adobe Acrobat, Adobe Illustrator

Laboratory Manager - 18 Years of Experience - Near 28037

Qualifications Summary Laboratory Manager with extensive experience in regulated pharmaceutical manufacturing and research and development with more than 10 years of management experience. Thorough understanding of regulated Laboratory environments including but not limited to GMP, GLP, GDP and 21 CFR Part 11. Quick learner with proven track record of driving success. Skilled at navigating FDA and vendor audits. Implemented...

Tags for this Online Resume: Project Leader, Project Management, Budgetary, Drafting, High Performance Liquid Chromatography (HPLC), Management, Planning, Rational, White Papers, clinical, phase, trial, gcp, protocol, pharmaceutical, Quality, LC/MS

Chemist - 20 Years of Experience - Near 53701

I am a Chemist with 20 years of pharmaceutical CRO experience. I have developed and validated ~ 75 methods for the analysis small molecule pharmaceutical compounds in biological fluids using LC/MS/MS. I have experience in most aspects if the industry, including project management, and study director roles.

Tags for this Online Resume: LC/MS/MS, Analytical Method Development, GLP regulations, Validation , Project management, SPE, Data Processing, Documentation, Project Manager, Analytical Chemistry

Biochemist - 20 Years of Experience - Near 95051

Professional Summary: * Superior problem solving skills, QC/QA validation, GLP protocol expert, FDA * qPCR designs, Elisa, SOP validation, Automated System Specialist, Statistical analysis * HPLC, Flow Cytometry, Chromotography, Analytical Chemistry, Sample preparation and Analysis

Tags for this Online Resume: Research, Filing, Packaging, Product Launch, Protocol, Allergy, Analytical Chemistry, Applications, Biomedical Industry, Chemistry

Director - 20 Years of Experience - Near 08520

ACCOMPLISHMENTS * Lead client teams and CDMOs in Product Risk Assessments, EHS Analyses, Regulatory Audits, FDA PAI readiness program, interfaced with US Environmental Protection Agencies for new and updated Air Emission and Wastes Water Effluence permits. Manage OSHA training and audit programs. Reduced product technical and compliance risks while saving safety-related operating cost by reducing planned budget by >10%. Ben...

Tags for this Online Resume: Engineering, Manufacturing, Compliance, ECMS, HVAC, Infrastructure, Material Handling, OSHA, Business Development, Management, director, consultant, regulatory compliance

Chemist

Summary * Experienced Quality Assurance scientist in the pharmaceutical and biotechnology industry working for over 17 years in a cGMP and GLP regulated environment. * Lead efforts in the business analysis for the group's business continuity program and the implementation of the Laboratory Information Management Systems (LIMS). * Knowledgeable in Project Management methodologies like 5S, LEAN and Six Sigma. * Skilled in ana...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Microsoft, Microsoft DOS, Microsoft Windows, Applications, Benefits, Business Analysis, Business Analyst, Documentation, Information Technology, pharmaceutical, sap

Biologist

Seeking a position to utilize my knowledge, skills, and abilities in the industry that offers competitive environment, and gain exposure to upcoming technologies while being resourceful, innovative and flexible. Hands-on experience in DNA and Protein isolation, Purification, SDS-PAGE, Cloning, Mammalian Cell Culture, Transfection, HPLC, PCR, RT-PCR, IVD Assay Development, NGS Data Analysis, Western blot, Immunohistochemistr...

Tags for this Online Resume: Documentation, Research, Assessments, CFR Part 11, Chemistry, Distribution, Electrophoresis, ELISA, High Performance Liquid Chromatography (HPLC), Immunization

In Between - 15 Years of Experience - Near 27572

QUALIFICATION SUMMARY Thirty-five years of pharmaceutical/biotech industry biotech with management experience. Able to adapt to rapidly changing business situations and move forward with change while using strong communication skills to facilitate a high level of collaboration among peers and co-workers. Broad background of experience and expertise in the following areas: * Quality Control/Quality Assurance * Team Developme...

Tags for this Online Resume: Training, Corrective Actions, Data Processing, Good Manufacturing Practices, Manufacturing, Quality Assurance, Test, Data Entry, Document Management, Filing

Quality Coordinator

SUMMARY Quality Assurance Manager with expertise in pharmaceutical and chemical, quality control and quality assurance areas. Managing and coordinating quality assurance functions of pharmaceutical and chemical industry from inception to completion while communicating horizontally and vertically in a highly regulated FDA/EU environment. Possess a background in both Fortune 500, entrepreneurial and start-up environments. Exp...

Tags for this Online Resume: Complaints, Quality, Quality Assurance, Quality Control, Compliance, Test, Audit, Corrective Actions, DSC, High Performance Liquid Chromatography (HPLC), rn

Biochemist - 15 Years of Experience - Near 92129

SUMMARY Research and development scientist with a broad technical expertise in microbiology and molecular biology in the Biotechnology and Pharmaceutical industry Multiple years of bench/hands-on extensive experience in microbiology and molecular biology for in vitro diagnostics assays (IVD) development for infectious diseases, food borne pathogen detection, genetic markers in field of oncology. Performed classic and molecu...

Tags for this Online Resume: Research, Atlas, Automation, Integrate, Microbiological Testing, Protocol, Test, Cancer, Diagnostics, Documentation

Biochemist - 4 Years of Experience

Tags for this Online Resume: pharmaceutical, sas, endotoxin, assay, product development, gmp, glp, dhf, sop, Research

Biological Technician - 18 Years of Experience - Near 02421

SUMMARY Quality Control Chemistry works, Internal/External Audits and Inspection, Maintain Laboratory update with Quality Management. Technical work and knowledge of Biotech/ Pharmaceutical QC/QA system with cGMP and GLP compliance, Practice Quality Management and ICH regulations guided by ISO 9000+. Complete COA for drug product and biologics. Maintain liaison with contract manufacturing (CMO/CTL) Operation and collect bat...

Tags for this Online Resume: CFR Part 11, Inventory, ISO, ISO 9000, Troubleshooting, Audit, Change Control, Chemistry, Documentation, pharmaceutical