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Online Resumes with "GLP GMP"



Industrial Microbiologist

To obtain a Food Safety Scientist position that will utilize my extensive Biomedical/ Pharmaceutical, Food and Manufacturing background and education. Experienced with FDA, EU, GLP, GMP, ISO 9001, HACCP and CFR requirements.

Scientist - 8 Years of Experience - Near 95695

PROFILE: 8+ years of success in biologic research, data analysis, project management and leadership, scientific writing and editing, teaching and mentorship, and collaborative biomedical-based engineering in university and lab settings. * 6 research publications, highlighting advancements in bone tissue engineering and biopharmaceutical delivery. * Podium presentations at seminars and conferences focusing on scientific netw...

Tags for this Online Resume: Manufacturing, OSHA, Research, Cellular, Good Manufacturing Practices, Project Management, Project Manager, Biomedical Engineering, Materials Science, Biomaterials, Science, Biomedical, Pharmaceutical, Cell culture, Scaramento, Tissue engineering, Tissue culture, Laboratory

R&D Scientist/Chemist

CAREER HIGHLIGHTS Systematic approach & dedication resulted in completion of key project milestones before deadline. Instrumental in formulation and development of consumer products as well as improving the current products for a world leading FMCG company. Championed the art of enzyme stability testing initially under supervision and then on own initiative. Got recognized for the post-graduate project due to significant im...

Tags for this Online Resume: Product Design, Audit, Chemistry, Product Development, Test, Test Plans, Applications, Centrifuge, Consumer Products, Good Laboratory Practices

Business Analyst - 7 Years of Experience - Near 08817

Professional Summary: * 10+ years of overall IT experience with 6+ years of Business Analyst / Project Coordination and management expertise in Healthcare and Pharmaceutical Industry. * Lead JAD sessions to aid in requirement gathering, prototyping and documentation of business and system needs via BRDs, FRDs User Stories, Use Cases, Workflows, Wireframes and Software Requirement Specifications. * Expertise in implementing ...

Tags for this Online Resume: Business Analysis, Business Analyst, Information Technology, Acceptance Testing, Active Server Pages, Adobe, Adobe Acrobat, Agile, ANSI, Ansi (Am Natl Stds Inst), PMP certified, VISIO,MS Project

Clinical Quality Assurance - 15 Years of Experience - Near 27513

Summary * More than eight years of Quality Assurance (QA) and regulatory experience abiding by GCLP, GLP, GMP, ISO/IEC 17043, GxP, and HIPAA. * Excellent problem solving, risk analysis and organization skills * Strategic thinker with strong interpersonal skills * Able to initiate and complete assigned tasks, work independently, and maintain team orientation skills * Professional, flexible and creative

Tags for this Online Resume: Standard Operating Procedures, Quality Management Plan, Quality Assurance, Internal, in-process, External, Vendor Audits, ISO, Word, Excel, Power Point, Study-Specific Plans, Good Laboratory Practices, Good Manufacturing Practices, Quality Assurance Training

Chemist - 15 Years of Experience - Near 64468

USA). Performed research with fish hemoglobin (Hb) adducts of PPCPs (namely nitro musk fragrance ingredients) Conducted method development researches for drugs and metabolites, personal care products and nitro aromatics through enzymatic metabolic processes in living organisms. Also monitored occurrence, fate and degradation products of drugs, PPCPs in different water sources and in aquatic organisms such as fish by GC-MS/M...

Tags for this Online Resume: Analytical Chemist,, Research Scientist,, R & D,, Pharmaceutical Company, Agriculture and Environmental, LC-MSMS, GC-MSMS, ICP-OES, Method development and Validation, Instrument trouble shootings, SOPs, GLP, GMP, Analytical Chemistry

Medical Scientist - 8 Years of Experience - Near 20854

Summary Research scientist with an excellent track record of productivity in R&D and regulatory (GLP/GMP) industry R&D experience (immuno-oncology) * Contributed to project completion for FDA IND filing by creating 8-10 stable antigen presenting cell lines, and 3 target lines to expand and test chimeric antigen receptor-modified T cells. * Optimized/Validated cell-based assays (proliferation, cytotoxicity, cytokine producti...

Tags for this Online Resume: Publications, Database, SoCs, Good Laboratory Practices, Good Manufacturing Practices, Communication Skills, Compliance, Corrective Actions, ELISA, Excellent track record

Quality Engineer - 15 Years of Experience - Near 10312

Summary of Qualifications * Provide validation services for pharmaceutical clients to be compliant with FDA regulations utilizing CSV methodology * Professional with a strong background in validation, quality, information technology, and chemistry domains for pharmaceutical and medical device industry * Proven knowledge of FDA regulatory requirements, including cGxP, GLP, GMP, Sarbanes-Oxley (SOX), 21 CFR 210/211, 21 CFR 58...

Tags for this Online Resume: Services, Data Migration, Legacy, Quality Assurance, Assessments, Audit, Management, Quality Management, Pharmaceutical, Quality, validation, CSV, business analyst

Clinical Research - 16 Years of Experience - Near 94547

SUMMARY of QUALIFICATIONS 16 years of experience as a Clinical Research professional in Biotech and Pharmaceutical industries. Well-rounded skill, as a CRA in Clinical Operations processes, Clinical Development, Regulatory, TMF and Data Management. Skilled in data audit/review Study start up, Study conduct, Vendor management, and Site monitoring activities extensive knowledge of GCP-ICH, GLP, GMP guidelines familiar with Ex...

Tags for this Online Resume: Protocol, Assessments, Audit, Clinical Research, Documentation, Pediatrics, Research, Clinical Management, Distribution, oncology, phase, trial, clinical, protocol, pharmaceutical, gcp, ich

Quality Manager - 20 Years of Experience - Near 31794

Summary: * Process results driven management professional with a deep and rich background in chemical and product manufacturing following GLP / GMP policies. * Expertise includes chemical, food and beverage production, and process R & D (actives, additives, fillers, drying, dying, P.S. grinding effectiveness, strength ads, and emulsifier additions) as well as correct analysis of such and stability evaluation of FP. * Knowle...

Tags for this Online Resume: Quality, Quality Assurance, Audit, Chemistry, High Performance Liquid Chromatography (HPLC), ISO, ISO 9001, Management, Test, Applications, steel, production, machine operator, Quality inspector

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

Chemist - 20 Years of Experience - Near 02467

PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities