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Online Resumes with "FDA regulatory"
Director, Medical Device/ Pharma - 15 Years of Experience - Seattle or Bay area opportunities
SUMMARY OF Senior Management, International Experience, Direct Report to CEO QUALIFICATIONS 15+ years in Management with 6+ years direct report to CEO. Built Healthcare R&D at an Applied Material Research Institute from ground zero to 40+ staff, mostly with Ph.D.s. Road mapping Institute's core platform technologies from conception, leading to new inventions, corporate licensing and product commercialization. Managed 30+ he...
Tags for this Online Resume: Insulin, Research, Biomedical Industry, Manufacturing, Management, API, Chemistry, Critical Care - Vascular, Research and Development, nanotechnology, surface chemistry, P&L, platform technologies, material science, Group leader, Department head, medical device, pharmaceuticals, skincare, tissue engineering, implants
Chemist - 4 Years of Experience - Near 17602
Professional Summary * Over 2+ years experienced in the field of Pharmaceutical Quality Assurance. * Ability to handle analytical method, cleaning and process validations. * Experience in issuing of line clearance at every step of batch manufacturing * Provide support to the various divisions for effective and efficient implementation of the Quality Management System. * Experience of preparing and analyzing information for ...
Tags for this Online Resume: Documentation, Forth Programing Language, High Performance Liquid Chromatography (HPLC), HVAC, Manufacturing, PDC, Quality, Quality Assurance, Test, Communication Skills
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
Software Engineer
Quality orientated Biochemist and Software Engineer who resolved CAPA, developed medical instrument software requirements and assays, and supervised and trained colleagues. Certified Scrum Master. Wrote and performed verification/validation black box/white box software testing with consideration for User Design and FDA regulations. Solved hardware and software issues. Built and maintained effective working relationships wit...
Tags for this Online Resume: Chemistry, Protocol, Regression Testing, Test, Test Cases, Diagnostics, Design Documents, Microsoft, Software, Unix, SCRUM Master, Agile software development, FDA regulatory, UX design
Clinical Research - 1 Years of Experience
enthusiastic and adaptable Administrative Management Professional offers Analytical 15+ years of successful performance in research management quality assurance and customer service industries. * Demonstrated success in donor management processes and compliance regulations * Proficient Excel Word Access PowerPoint Outlook * Trained and experienced in FDA regulatory practices and compliance procedures * Trusted to successful...
Tags for this Online Resume: Compliance, Assistant, Coordinator, Data Entry, Documentation, Clinical Research, Support, Compliance
Manager - 10 Years of Experience - Near 91387
QUALIFICATIONS * Customer-focused / diplomatic / tactful / positive / upbeat * Superior Manager / coach / trainer / mentor / solution-oriented / highly organized * Persuasive oral / written communicator / high level of motivation / aptitude * Interact well at all levels internally and externally / excellent stability * Adept Team Leader or function well as an individual contributor * Resourceful problem solver / outstanding...
Tags for this Online Resume: Compliance, Distribution, Test, Collection, Team Lead, Customer Service, Flooring, Inventory, Inventory Control, Retail, assistant manager, management
Biomedical Engineer - 16 Years of Experience - Near 01757
Professional Summary 20+ years' success leading engineering innovation for high-growth organizations * Over 20+ years of extensive experience in Electrical & Electronic Engineering professional and Technical lead for many engineering projects including "Flex-Cardio product performance test in the production line the CO2 transducer Exchange and repair Managed daily product build in production floor - Manage Projects processi...
Tags for this Online Resume: Low Voltage, Debugging, MOSFET, Program Manager, Project Management, Project Manager, Test, Total (Db For Lg Comptrs), Total Systems, Medical
Compliance Manager
Professional Summary Competent, innovative, and forward-thinking management professional with extensive experience in advanced technology manufacturing environments and a proven track record of sustaining productive, high quality and cost-conscious production operations for mid-size and major corporations. Recognized for a thorough understanding of all processes, methods, procedures, equipment and materials used in high-tec...
Tags for this Online Resume: ANSI, Ansi (Am Natl Stds Inst), Audit, Compliance, Data Entry, Enterprise Software, ESS, Failure Analysis, ISO, Microsoft
Medical Scientist
COVER LETTER: To whom it concerns: Please consider the following skill set: * Eleven years as the Medical Science Liaison (MSL) and Founding Chief Science Officer for Mitomics Inc (DBA as MTDNA Life Sciences), an Oncology Biomarker Discovery Company: o Worked with physicians to increase market uptake of company products o Helped design marketing material for both consumers and physicians o Researched oncology markets for hi...
Ideal Companies: Abbott, Sanofi
Tags for this Online Resume: Hematology, Oncology, Research, Magnetic Resonance Imaging (MRI), Market Research, MRI, Biopsy, Cancer, Dba (Database Admin), Urology
Clinical Research - 1 Years of Experience - Near 10710
Areas of Expertise * Direct patient contact * SOPs Implementation * FDA regulatory knowledge * Clinical Trials * Managerial
Tags for this Online Resume: Psychiatry, Data Management, Management, Accounting, Audit, Clinical Research, Data Entry, Evaluate, Forecast, Hepatitis
Quality Coordinator - 0 Years of Experience
Summary: * Extensive experience in clinical data management, pharmaceutical, and device research industries. * Experience working with Adverse Event Reporting and Medical Device Reporting. * Strong analytical, problem resolution, and project management skills. * Proficient in monitoring and managing record retention timelines for all clinical and regulatory documents and assistance in the preparation and review of documents...
Tags for this Online Resume: Data Entry, Database, Distribution, Filing, Documentation, Licensing, Medical, Microsoft Access, Regulatory Affairs, Research, clinical research
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
