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Online Resumes with "clinical quality assurance "
Clinical Quality Assurance
Senior Drug Safety SME
Clinical Quality Assurance - 15 Years of Experience - Near 27502
Tags for this Online Resume: Root Cause Analysis, ISO, Corrective Actions, Management, Policies and Procedures, Process Improvement, Quality Assurance, CAPA, Quality, Manufacturing, cGMP, CFR 21, Teamwork, Auditing, Deviation Management, SPE, ASQ CQIA, Calibration/Validation, Product Release, Direct observations, Training, MS Suites, EU Regulations, CLIA
Quality Systems Specialist - 20 Years of Experience - Near 94545
Summary * Multiple years' experience and thorough understanding of technical and business requirements for Biotech in clinical and commercial multi-product manufacturing facility. * Knowledge of regulatory expectations and requirements for protein purification facilities and industry standards and practices, manufacturing processes, cleaning validation, safety principles, quality systems, cGMPs, engineering design fundament...
Tags for this Online Resume: GMP, Troubleshooting, NPI, Change Control, Data Analysis, Management, Manufacturing, Product Development, Quality, Quality Assurance
Biologist - 13 Years of Experience - Near 07208
Qualifications Summary Highly competent, diligent, and detail-oriented management professional, equipped with extensive experience and expertise focused on various areas of quality improvement, process validation and qualification, manufacturing, risk analysis, as well as implementation of standard procedures and policies within the pharmaceutical industry. Possess solid instrumental analysis skills and expertise in categor...
Tags for this Online Resume: Management, Complaints, CFR Part 11, High Performance Liquid Chromatography (HPLC), FDA, New Jersey, MSDS, Policies and Procedures, Process Improvement, Protocol, CAPA
Clinical Quality Assurance
Tags for this Online Resume: Audit, Budgetary, Good Clinical Practices, Clinical Research, Data Management, Management, Research, Complaints, Documentation, ISO
Clinical Quality Assurance
SUMMARY OF QUALIFICAITONS * Global and domestic cGxP operation, quality and packaging experience in medical/precision and diagnostic devices, pharmaceuticals and biomedical industries * Managed Chemistry and Manufacturing Controls: including API sourcing, vender/raw material qualification, formulation, product/process development, scale-up, clinical supplies, technology transfer and validation * Wrote and compiled CMC porti...
Tags for this Online Resume: Cancer, Consumer Products, Engineering, OTC, Process Engineering, Product Development, Risk Analysis, Commercial Production, Team Lead, API
Clinical Quality Assurance - 7 Years of Experience - Near 92127
Summary Principal Quality Assurance Engineer with over 20 years of experience in both hardware and software quality engineering and compliance, with equal accomplishments in quality engineering and quality management. Extensive experience applying design controls to new product development of regulated class II Infusion and IVD medical device instrumentation, for electrical, mechanical, and embedded software driven medical ...
Tags for this Online Resume: Complaints, Instrumentation, Integrate, ISO, ISO 9001, Reliability, Audit, Chemistry, Compliance, Consumer Products
Clinical Quality Assurance
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
Clinical Quality Assurance
Decorated Leader | Award Earning Manager | Strategic Operations Manager | Change & Performance Improvement Leader | Exceptional Communicator | Subject Matter Expert
Experienced, highly-decorated leader and award-earning manager with over 20 years of U.S. Army experience in coaching, teaching, and mentoring personnel. Directed and trained supervisors, coordinated operations, implemented programs analyzing data, and resulted in significant program cost-savings. Improved patient/customer safety, addressed internal/external concerns, reduced wait-times, and increased overall satisfaction. ...
Ideal Companies: Shire Pharmaceutical, Sage Pharmaceutical, Novocure Pharmaceutical, Alexion Pharmaceutical, Sanofi Pharmaceutical, Pfizer, Boston Medical Center, and Beth Israel Deaconess Medical Center.
Tags for this Online Resume: Operations, Program Management, Quality Assurance, Scope, Budget, Leadership, Time Management, Human Resources, Physical Security, Security
