CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "FDA Regulations"

Clinical Quality Assurance - 10 Years of Experience - Near 19454

SUMMARY My work as a Quality Assurance professional has afforded me the luxury of possessing vast workplace skills. Notable career expertise includes, but is not limited to an ability to assess manufacturing conditions, spot potential nonconformances and take preventative/ corrective actions, utilizing Lean Implementation Methodologies. I have been conditioned to assure US/EU/FDA regulations in pharmaceutical, non/clinical,...

Tags for this Online Resume: Quality Assurance, Test, Manufacturing, Audit, Compliance, Consulting, Documentation, Management, Metrics, Packaging

Medical or Health Services Manager - 10 Years of Experience - Near 07436

Professional Summary * Detailed clinician with over 10 years Medical Technologist experience performing complex detailed testing in a clinical research laboratory setting. Investigator initiated research projects with compliance background. * Skilled Pharmacy Technologist with over 10 years' experience in pharmacy leadership, technology, and drug development * Diligent, accurate and reliable Laboratory Technologist with a r...

Tags for this Online Resume: ELISA, Protocol, Cardiology, Compliance, Critical Care - Neurology, Critical Care - Vascular, Data Analysis, Good Clinical Practices, Insulin, Management

Supply Chain Manager - 10 Years of Experience - Near 42301

Inventory and Account Management Specialist in FDA regulated GxP environment seeks challenging position where I can utilize my skills in supply chain, accounting and software systems.

Ideal Companies: Amazon

Tags for this Online Resume: Supply Chain, Logistics, Distribution, Purchasing, Inventory, Inventory Control, Biomedical Industry, Inventory management, Management, Regulatory Affairs

Quality Assurance Specialist - 14 Years of Experience - Near 34685

Summary of Qualifications Over eleven years in a regulated environment including custom built applications, clinical based computer systems, IVRS systems, and data acquisition systems. Seven of those years in an IT management role. Successfully lead teams in promoting quality assurance throughout the software development life cycle (SDLC), both Waterfall and Agile/SCRUM methodologies. Successful in the development and imple...

Tags for this Online Resume: Architect, Project Management, Consulting, Quality Assurance, Software Testing, Systems Engineer, Test, Training, Account Management, sql, agile, html, software, requirements management, requirements gathering, change control, configuration management, project management, audit, management, SDLC, waterfall

Clinical Research - 9 Years of Experience - Near 38654

Career Summary Pharmacovigilance Director of consumer care division with an in-depth knowledge of Food and Drug Administration (FDA) regulations governing the reporting of adverse events and experienced in a GMP, compliance-driven environment. An articulate and positive communicator with proven effective management of staff, workload, vendors and associated processes to maintain exceptional quality, consistency and complian...

Tags for this Online Resume: Documentation, Management, Regulatory Affairs, Compliance, Integrate, Outsourcing, Quality, Risk Management, Triage, Audit, pharmaceutical, regulatory, Drug safety, clinical trials, research

Research Assistant - 1 Years of Experience - Near 28273

SUMMARY OF QUALIFICATIONS: * Experience and in depth knowledge of cGMP, FDA regulations, MSDS and NFPA, aseptic techniques, and batch processing * General knowledge of entry-level process technician in bioprocessing, pharmaceutical, and chemical manufacturing * Hands on experience in analytical/laboratory methods * Hands on experience with routine urine specimen collections * Experienced in blood drawing procedures to inclu...

Tags for this Online Resume: Phlebotomy, Venipuncture, Documentation, Policies and Procedures, Benefits, Financial, Medical, Microsoft, Microsoft Office, Microsoft Windows

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

Dietician or Nutritionist - 10 Years of Experience - Near 90272

Summary With a Background of clinical medicine, molecular biology & Naturopathy, Evaluation of natural ingredients with scientific knowledge for safety & clinical based efficacy has been my core interest. Formulation development and manufacturing management of nutraceuticals and cosmaceuticals with cGMP HACCP application/compliance has been my major professional engagement. - Experience & Expertise in cGMP manufacturing man...

Tags for this Online Resume: Herbal medicine, Research and Development, Manufacturing, Microsoft Internet Explorer, formulation development, Nutraceuticals, Cosmaceuticals, Herbal extraction, Molecular Biology, Pharmaceutical Industry

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

Programmer Analyst - 8 Years of Experience - Near 22042

PROFESSIONAL SUMMARY * Over 8 years of experience in Information Technology field with strong emphasis in SAS Application Analyst/ Programmer with 3+ years of hands on experience and professional experience in Clinical Trial projects and also worked as Application Analyst in the CROs, Healthcare and Pharmaceutical industries. * Experience in analyzing and coordinating clinical data, generating detail summary reports and dat...

Tags for this Online Resume: Management, Oracle, Oracle 9i, Information Technology, Process Improvements, Coding, Health Care Industry, HyperText Markup Language, Manufacturing, sql, SAS analyst

Quality Assurance Director - 11 Years of Experience - Near 44074

SUMMARY OF QUALIFICATIONS OSHA, ISO standards, FDA GMPs, and blood establishment FDA regulations * Microsoft Office * Trainer and public speaker * Hematology, Blood Bank, Chemistry, Serology Testing

Tags for this Online Resume: Chemistry, Instrumentation, Documentation, Good Manufacturing Practices, Management, Manufacturing, Operational Excellence, Quality, Quality Assurance, Root Cause Analysis

Clinical Regional Monitoring

Therapeutic experience in IVD Oncology Hematology Orthopedics GI Cardiology Melanoma ENT Multiple Sclerosis and ADHD Extensive knowledge of FDA regulations ICH guidelines GLPs GCPs and SOPs * Monitoring experience of national and international sites for PSSVs SIVs IMVs and COVs * Ability to identify issues and resolve appropriately * Experience multiple EDC systems and platforms

Tags for this Online Resume: Accounting, Policies and Procedures, Project Management, Project Manager, Protocol, Documentation, Cardiology, Clinical Research, Orthopedics, Research