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Online Resumes with "Method Validations"
Scientist - 11 Years of Experience - Near 11779
Analytical method development by using Quality by Design approach. Risk analysis, FMEA, Control strategy and mitigation plan during the analytical methods development. Analytical method Validations as per ICH. Stability studies as per the product requirement.
Tags for this Online Resume: Analytical method development, HPLC, GC, ICH, QbD, DoE, FMEA
Chemist - 10 Years of Experience - Near 28025
Perform finished product testing, using HPLC and wet chemistry. I am looking for job opportunities in a new location where I can increase my skills in the areas of method validation and stability. I am interested in working in a safe environment, where there is open communication and the opportunity to work independantly as well as part of a team.
Ideal Companies: Small scale pharmaceutical companies
Tags for this Online Resume: HPLC, UPLC, GC, UV/VIS, EMPOWER PRO SOFTWARE, Karl FISHER, GMPs, DISSOLUTION, GS, EXCEL, MICROSOFT WORD, FT-IR, cGMPs, Facility, Lab and Notebook Auditing, Facility monitoring and sampling, Lab and Notebook Auditing, EMPOWER , cGMP , AUDITING, MONITORING, TESTING
Clinical Quality Assurance - 20 Years of Experience - Near 94403
QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.
Ideal Companies: small start-up company
Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)
Microbiologist, Analytical Chemist, HACCP Leader, Quality Assurance - 8 Years of Experience - Near 77035
Seeking a Quality Manager position or Plant Manager position. My background is in molecular biology and microbiology, as well as Analytical Chemistry. I'm also performing all of the duties of the quality manager. I work and have worked with Ion chromatograph (IC), GCMS, LCMS, wet chemistry. I'm the food safety leader in charge of HACCP, I lead the factory through audits for re-certification. I'm well versed in regulatory ...
Tags for this Online Resume: Houston, HACCP, FDA, regulatory compliance, Quality assurance, Food Safety, Microbiology, ASQ
QA ASSOCIATE - 3 Years of Experience - 08873
• Ensure implementation of cGMP, GLP and GDP • Monitoring processing and laboratory activities in the facility on a daily basis • Hosting regulatory audits • Member of internal audit team • Preparation and implementation of Standard Operating Procedures, Stability Protocols, Master Batch Production Records, etc. • Evaluation and Qualification of vendors for raw materials, packaging materials and contract services • Samplin...
Tags for this Online Resume: QUALITY ASSURANCE, QA TECNICIAN, VALIDATION, DOCUMENTATION, QA AUDITOR, BMR, Test, Audit, Documentation, Internal audit, Manufacturing, Microsoft, Microsoft Office, Packaging
QC Manager/Method Validation Chemist
Looking to take my knowledge in laboratory quility to the next level
Tags for this Online Resume: Test, Management, High Performance Liquid Chromatography (HPLC), Instrumentation, Microsoft, Microsoft Excel, Green Belt, Manufacturing, Quality Assurance
Chemist - 15 Years of Experience - Near 07747
SUMMARY OF FUNCTIONAL EXPERIENCE AT AKORN: Hands-on experience with pharmaceutical analysis using HPLC, GC/HS, Spectroscopy, physical and wet chemistry. Familiarity with Analytical Chromatography software Backman Peak-Pro, Perkin Elmer TotalChrom and recently implemented Thermo Fisher Chromeleon. Trackwise software for OOS, OOT and deviation investigation. iStability software for stability monitoring and trending. * Quality...
Tags for this Online Resume: Pharmaceutical, Pharmaceutical Industry, Quality Control Chemistry, Quality Control Chemistry, Quality Control, Accredited Pension Representative, Audit, QC Manager
Chemist - 11 Years of Experience - Near 27104
Adaptability, well-developed interpersonal communication skills, creativity, perceptive problem-solving ability, and a driven work ethic are skills that I offer to a prospective employer. Through industrial and academic lab experience, I gained invaluable Quality Assurance experience, which, as a proficient writer, can add to the productivity of an organization. I am a dependable team member or proficient as an independen...
Tags for this Online Resume: Diagnostics, Derivatives, Filing, Neurological, Assessments, Best Practices, C Programming Language, Chemistry, Consulting, HYGIENE, Chemist, Organic, Researcher, Nucleosides, Synthesis, Spectroscopy, Spectrophotometry, HPLC, GC-MS
Chemist - 15 Years of Experience - Near 07059
PROFILE Analytical Chemist with over 15 years of experience in the Pharmaceutical industry. Experience in developing and validating analytical methods to satisfy regulatory requirements. Broad range of knowledge and experience working with new chemical entities (NCE), raw materials and finished products including structure elucidation, testing, quality assurance, regulatory compliance and submission. Known for ability to tr...
Tags for this Online Resume: ICH, Chemistry, method validation, Test, Pharmaceutical, Quality, GMP, Analytical method development, UPLC, HPLC, GC, LC-MS, LC-MS, GC,HS-GC
Microbiologist - 20 Years of Experience - Near 45066
Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...
Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures
Scientist - 6 Years of Experience - Near 20705
Self-driven and detail oriented research scientist with over ten years of experience in research and development I have more than 10 years of experience in the following fields * Chromatographic / spectroscopic method development, validation, and analysis (GC - MS, LC - MS, CE, Q-TOF-MS, GC-TOF-MS, MALDI, Electrophoresis, ) * New drug candidate identification from natural sources * Biomarker development * Handling large dat...
Tags for this Online Resume: Cancer, Proteinx, peptide, Mass Spectrophotometer, HPLC, UPLC, MALDI-TOF-MS, Method developmet, GC-MS, MS/MS, Method validation, Chemometric analysis, SIMCA, SPSS, Microsoft
Not Listed - 7 Years of Experience - Near 30046
Summary * Six Sigma project manager experienced working on process improvements on cross functional teams personnel * Recognized Rituximab density calculation error within LIMS Master Data and initiated appropriate CAPA remediation procedures which saved subsequent downstream lots from disposal * Analyzed, identified, and implemented cost savings opportunities for process improvement and operational excellence * Produced re...
Tags for this Online Resume: Process Improvement, Inventory, Management, Inventory management, Integrate, Operational Excellence, Process Improvements, Quality
