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Online Resumes with "483 Responses"
Senior Quality Assurance Specialist
Summary of Qualifications Dedicated and solutions oriented professional with 14 years of medical device background mainly in Quality & Compliance * Highly motivated with demonstrated ability to set appropriate and effective priorities and implement decisions to achieve both immediate and long-term goals while managing multiple tasks and completing priorities. * Effective communication and inter-personal skills with all leve...
Tags for this Online Resume: Quality, Quality Assurance, Corporate Audit, Manufacturing, Raleigh RTP, Compliance, Internal audit, Supply Chain, FDA
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
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