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Online Resumes with "gmp"



Quality control team leader,Montreal

Result oriented professional with a master’s degree in biology and over 7 years of Pharmaceutical industry experience in positions of increasing responsibilities in cGMP production under sterile conditions, quality assurance, and quality control and process development. Skilled at leading multiple projects, as well as developing and managing laboratory operations and budgets. Familiar with both the US and Health Canada’s or...

Tags for this Online Resume: GMP, CRA certification, Quality Assurance, SOPs , Bilingual French/English, cGMP, Virology/Oncology, HYGIENE, Inventory, Inventory management, clinical, pharmaceutical, trial

Supervisor

Mr. Thomas M. Golden is a Senior Validation Engineer with 25 years of experience in the pharmaceutical and biotech industries. Mr. Golden has extensive experience in both management and team player roles in utilities process development scale ups technology transfer cGMP GDP SOPs FDA regulations and critical utilities. He has excellent oral and written communication skills and is an innovative leader who believes in teambui...

Tags for this Online Resume: Manufacturing, Procurement, Utilities, Packaging, Protocol, Acceptance Testing, Management, Pharmaceutical, manager

Chemist - 10 Years of Experience

A result oriented individual, having MS Chemistry and MS interdisciplinary Studies (Chemistry and Medicinal Chemistry) with experience of over 5 years in chemical research. Possess research experience in Organic Synthesis, Organometallic Chemistry, and Drug Development. An effective communicator & proactive planner with strong analytical, problem solving and organizational abilities.

Tags for this Online Resume: 5S, Chemistry, Quality Assurance, SAP, Analytical Chemistry, cGMP, NMR, LCMS, HPLC

Production Manager - 20 Years of Experience - Near 32825

PROFILE A strategic results-driven Quality / Validation, Operations, Engineering, and Project Management Professional with more than 15 years of experience in world class Pharmaceuticals and Medical Device industries. Vast experience compliance of cGMPs and associated regulations, investigations and corrective actions (NC & CAPA), remediation's planning/budgeting and execution of commitments to FDA, equipment and facilities...

Tags for this Online Resume: Quality Assurance, Budgeting, Complaints, Compliance, Consulting, Corrective Actions, CVS, Distribution, Engineering, Management

Biochemist - 4 Years of Experience

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

Chemical Engineer

SUMMARY Accomplished and innovative Biotechnology Professional/Chemical Engineer with significant experience in industrial and pharmaceutical biotechnology. Areas of particular expertise include protein purification, characterization, formulation, process development, analytical development and production. Proven track record of developing, commercializing and providing application support for new products, including interf...

Tags for this Online Resume: Laboratory Work, Integrate, Leadership, Product Development, Product Launch, Manufacturing, Research, Planning, Engineering, Filing

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

Production Supervisor - 20 Years of Experience - Near 92583

Summary: I have been in the Food Industry for over 30 years, and worked in numerous departments such as Assembly, Bakery, Bagged Salads and Grade and Pack. In each department I've had a positive impact on labor cost and yield by constantly managing run rates, change over times, output per man hour, waste and giveaways. I also work to standardize schedule adherence, service levels, processes and GMP's (General Manufacturing ...

Tags for this Online Resume: Balance, Quality, Quality Assurance, Quality Control, Training, Management, Information Technology, Manufacturing, Process Improvement, manufacturing, production, reliability, machine operator, process improvment

Medical Scientist - 20 Years of Experience - Near 91401

* Accomplished researcher with strong skills & knowledge in various Molecular Biology, Cell Biology & Biochemistry techniques. Research papers published in top professional journals. * Skilled in Circulating Tumor Cell (CTC) capture, Liquid biopsy platform, Biomarker development, Multicolor flow cytometry, Cell based assay development, Immunofluorescence staining of CTCs, Fluorescence in situ hybridization of CTCs, Fluoresc...

Tags for this Online Resume: ELISA, Microsoft Excel, Microsoft PowerPoint, Oncology, pharmaceutical, Fluorescence in situ hybridization, Cell based assay, Multicolor flow cytometry, Cell culture, Biomarker development, Genetics, Molecular Biology, Next generation sequencing, Liquid biopsy, Microfluidic, Antibody discovery and qualification, Primary immune cell culture, Immunoassay, Western blot, Immunohistochemistry, Immunofluorescence staining, Biotech, Cell biology, Biochemistry, Immunology, Small molecule screening, PCR, qPCR, Circulating tumor cell isolation, Blood prep, Process development, Product development, Bioassay, Highthroughput imaging, Highthroughput data analysis

Chemical Plant System Operator - 15 Years of Experience - Near 60101

SUMMARY * Bachelor Degree in Science in Biology and has extensive years of laboratory experience. * Adherence to GMP, ISO Standards and OSHA procedures. * Performed PH, percent solids, conductivity, UV/Vis, Gel Electrophoresis, Carl fisher, fill weight as additional testing including simulation runs on the actual diagnostic instruments. * Knowledge / experience in Process Validation, Test Method Validation, Vendor Qualifica...

Tags for this Online Resume: lab tech , R, Safety, Tech Supp Lab Tech, word, Complaints, Distribution, Electrophoresis, Failure Analysis, OSHA, production, maintenance, manufacturing

Chemist - 20 Years of Experience - Near 84341

Areas of Expertise * Batch Record Review * Transfer of Analytical Data (TAP) * GMP & Regulatory Affairs * Remediation * Process Validation * Deviation Resolution * Lab Environmental * CAPA Investigation * Quality Compliance & Assurance * Product Quality Management * Manufacturing of Sterile and aseptic products * 21 CFR, EU Regulations, and ISO 13485 * Safety and Regulatory Compliance * HPLC for API and Finished Product usi...

Tags for this Online Resume: Manufacturing, Pharmaceutical, High Performance Liquid Chromatography (HPLC), Management, Pharmaceutical Industry, Research and Development, Regulatory Affairs, API, Application Program Interface

Quality Manager - 20 Years of Experience - Near 37064

Manager - Accountable for all aspects of ISO 9001:2008 quality management system and quality control. * Lead a staff of 8 quality professionals provided unprecedented level of service to both internal and external customers. * Developed formal validation and design procedures for medical device components compliant to cGMP. * Led all CAPA (RCCA) efforts. Enhanced successful closure by 70% and strengthened root-causes and tr...

Tags for this Online Resume: Science, Acceptance Testing, Protocol, Quality, Quality Assurance, Test, Manufacturing, Corrective Actions