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Online Resumes with "fda "



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

Featured Profile

Manager, Sterile Processing

To secure employment utilizing my experience within Peri-Operative Services that will take advantage of and fully use my maturity, strong work ethic, also where I can maximize my management skills, quality assurance, program development, and training experience.

Tags for this Online Resume: Management, Kronos, Kronos (Labor Mgmt Sys), Medical, Medical/Surgical, Packaging, Surgical, Instrumentation, Process Improvements, Sterile Processing Educator, Impress Implementation Manager, Manager Sterile Processing, Sterile Processing

Veterinary Technician

Summary of Qualifications Accomplished laboratory animal veterinarian with 15+ years of experience working in academia and in the biotech industry. Proven ability to communicate with staff at all levels of an organization, and with scientific and non-scientific backgrounds. Experienced at working under USDA, APHIS, DEA and GLP requirements, with expertise in the management of support staff and animal colonies in AAALAC accr...

Tags for this Online Resume: Imaging, Radiation, Surgery, Surgical, Toxicology, Biomedical Industry, Training, Academia, Laboratory Animal Medicine, Veterinary Medicine, Nonhuman Primates

Clinical Research

PROFESSIONAL SUMMARY: Licensed Pharmacist from India with Masters in Pharmacology. Over 7+ years of experience in the Pharmaceutical industry with focus in Pre-clinical and clinical trials and a strong understanding of cGMP, GCP, FDA regulation and ICH guidelines. Have an Extensive knowledge as a Quality Assurance officer and outstanding interpersonal skills with a track record of establishing positive relationships with cu...

Tags for this Online Resume: Clinical Research, Email, Management, Project Management, Project Manager, Protocol, Research, Canvas

Study Coordinator

Summary Study Coordinator with 6 years' experience specializing in technical support of animal studies requiring GLP compliant interpretations, analysis, documentation, and reporting of results per FDA regulations beginning with protocol development support and creation of shell reports resulting in a Final product ready for FDA Regulatory Filings. Areas of Expertise / Core Competencies * Highly dependable, focused and dete...

Tags for this Online Resume: Documentation, Good Laboratory Practices, Protocol, Analytical Skills, Biomedical Industry, Quality, Quality Assurance, Coordinator, Medical Devices, Regulatory

Quality Engineer - 19 Years of Experience - Near 77459

SUMMARY Highly motivated, goal oriented, and efficient Quality Assurance professional with expertise in regulatory compliance, documentation, auditing, and process improvements. Known for ability to complete multi-faced tasks within strict time constraints. Demonstrated expertise in setting priorities and establishing appropriate detailed documentation to meet deadlines using strong clinical, analytical, and technical skill...

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Audit, Complaints, ISO, ISO 9001, Management, Protocol, Manufacturing, ISO 13485

Operations Manager - 12 Years of Experience - Near 11729

Summary of QualificationsDedicated, hard working, and enthusiastic leader with over 10 years of experience in restaurant management and airline catering. Expertise in strategic planning, managing operations, improving efficiency of operations, and team building. Capable of identifying areas of strengths and weakness as well as implementing company policies, standards, changes in operations, and restaurant systems that optim...

Tags for this Online Resume: Airlines, Process Improvements, sheets, Complaints, Quality, Quality Assurance, Test, Management, Communication Skills, Dec

Clinical Research - 1 Years of Experience - Near 27704

A goal-driven dependable and dedicated management professional with over 12 years' solid experience in Clinical Data Management operations at a non-profit organization. Has extensive knowledge of GCP ICH and FDA regulatory requirements regarding management of clinical trials data. Expertise in data management practices for paper studies as well as electronic data capture systems. Has a proven ability to effectively communic...

Tags for this Online Resume: Data Management, Email, Management, Query, Training, Documentation, Clinical Research, Compliance, Data Entry, Project Management

Clinical In-house Monitoring - 6 Years of Experience - Near 07621

SUMMARY OF QUALIFICATIONS Pharmaceutical professional with 5+ years of clinical research experience in management and monitoring. Seeking new and exciting opportunities in new therapeutic areas to expand my expertise. Known for building strong relationships with clients and partnering with management teams to ensure quality services, compliance and efficiency. Manage Clinical Research, third party vendors, and clinical inst...

Tags for this Online Resume: Fraud, ICD-9, Insurance, Medical, Query, Management, Good Clinical Practices, ICH, Documentation, Clinical Research

Clinical Regulatory Affairs - Boston Area

Tags for this Online Resume: IRB, FDA, Clinical Research, Unix, Regulatory Affairs, NDA, GLP

Clinical Research Associate- 3 years Experience

To obtain a position as Clinical Research Associate (CRA) with a pharmaceutical / biotechnology firm where my knowledge and experience along with my strong technical and procedural skills in clinical monitoring can be utilized and challenged to meet the growing needs for clinical trials of new drugs and medical devices in multiple therapeutic areas. Also, to contribute to reducing the time it takes for a new drug to progres...

Clinical Research Associate

SUMMARY: To apply my knowledge of FDA Good Clinical Practice guidelines/ICH guidelines, extensive site/field Clinical Director, Site Lead Study Management, in addition to my experience with various therapeutic areas of medicine, to a position as a Clinical Research Associate. AREAS OF EXPERTISE * Management * Interview candidates and either make a selection decision or recommend individuals for hire. * Able to manage multip...

Tags for this Online Resume: Clinical Research, Research, Accounting, Acquired Immune Deficiency Syndrome (AIDS), Advertising, Amazon Elastic MapReduce, Audit, Basic First Aid, BLS, Budgeting