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Online Resumes with "FDA audit"
Clinical Research - 15 Years of Experience - Near 75089
I have been doing contract work For the last 2 years In house site audits Getting site ready for FDA audits
Tags for this Online Resume: Management, Project Management, Documentation, Training, VITAL SIGNS, Protocol, Audit, Banking Industry, Best Practices, Biomedical Industry
Quality Assurance Manager / Vendor Manager - 20 Years of Experience - Near 60060
SUMMARY: Experienced, dedicated, Quality Assurance professional and trainer who provides the knowledge and skills to assist with and drive projects as part of a team or as an individual contributor. * 20+ years of experience in pharmaceutical research, 15+ in Quality Assurance * Experience with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH), Good Laboratory Practice (GLP), Vend...
Tags for this Online Resume: Quality Assurance, Test, Clinical Research, Research, Audit, Management, Pharmaceutical Industry, Development Activities, Policies and Procedures, Vendor Management, Clinical, GCP, GLP, Training, Nonclinical research, Preclinical, Early phase clinical research
Clinical Research
ACCOMPLISHMENTS * Worked with 50 different sponsor and CRO companies on various GI studies * Managed Bunion investigational study with 300 patients. * Three FDA audits without 483. * Met all recruitment targets within required study timeframe * Managed regulatory binder for studies, post start-up * In depth knowledge of Microsoft packages ( Word, Excel and power point) Experienced with Oracle, Inform, Medidata eDC programs ...
Tags for this Online Resume: Oncology, Research, Clinical Research, Microsoft PowerPoint, Microsoft Word, Oracle, Recruiting, Staffing & Recruitment, Computer Aided Software Engineering, Good Clinical Practices
Clinical Regional Monitoring - 12 Years of Experience - Near 30339
Profile A conscientious Research Associate with 30 years of diverse experience in product development, quality assurance as well as technical service and clinical research. A persistent self-starter experienced in operating and training personnel in a variety of analytical instrumentation and procedures. Successful in finding innovative solutions to a wide range of problems in a team environment or alone. inVentive Health C...
Tags for this Online Resume: Clinical Research, Research, Training, Management, Support, Technical Support, FRACTURES, Instrumentation
Director of Quality - 24 Years of Experience - Near 11801
Professional Summary Highly effective professional offering 30 years of US global quality leadership experience developing strategies, improvement action plan and solutions. Dedicated leader to bring organizations together, focusing on hi performance culture leading to improvement and efficiency. Built fully engaged team that is motivated to achieve metrics and deliver ROI. Lead and empowered cross functional teams to impro...
Ideal Companies: end of the year 449.00 + 4 months of our service. resume rewtire and cover letter.
Tags for this Online Resume: TQM (Total Quality Management), Manufacturing, Assessments, Audit, Quality, Quality Management System, HACCP, Continuous Improvement, PCQI, Supplier site and internal audits, USDA, FDA, ISO 9001, SQF, BRC, ISO 22000, ERP, OOS, Investigation, CAPA, NCR
SENIOR PERSONAL CARE PRODUCTS CHEMIST WITH 15 YEARS OF EXPERIENCE IN FORMULATION, TESTING, AND REGULATORY STANDARDS
Applying my Education and Experience in Every Possible Way to achieve the Maximum Profitability and lowest Cost Possible to the Employer
Ideal Companies: Johnson and Johnson, Proctor and Gamble, Unilever, Colgate - Palmolive
Tags for this Online Resume: ANSI, Ansi (Am Natl Stds Inst), OTC, Quality, Chemist, Formula, Personal Care, Cosmetics, Household, QC, R & D, FDA, Consult
GENERAL MANAGER / OPERATIONS EXECUTIVE
Top-producing and proactive business leader with over 20 years combined experience impacting the performance and viability of top-tier transportation and logistics organizations via outstanding process improvement measures, resource allocation, and client base development. Highly adept at off shoring/outsourcing initiatives and corporate turnaround and consolidation activities. Committed team builder with a proven track rec...
Ideal Companies: Companies 500 employees or larger
Tags for this Online Resume: Team Building - Training/Development, P&L - Budgeting - Strategic Planning, Operational Streamlining, Inventory Management - WMS - SAP - ISO, Project/Budget Management, Fleet Management, Documentation, Pricing, Business Development, Distribution
Department Manager - 20 Years of Experience -
I am seeking a professional position in a management role that leverages my 20 plus years of quality, manufacturing & training skills in a highly regulated environment. I seek an employer who values work ethic, emphasizes detail oriented skills and promotes employees who are seen as value added assets.
Ideal Companies: Core RX, Valeant, Catalant, Baxter, Watson, Thorne Research
Tags for this Online Resume: Quality Manager, Pharmaceutical Manufacturing, Investigations, Customer Complaints, Leadership, Management, Problem Solving, Complaince, detail oriented
QA Professional - Former FDA CDER 15 years experience, ASQ CQE, CQA, CQMgr-OE, Microbiologist,- DC
Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits
Ideal Companies: Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer
Tags for this Online Resume: TrackWise, Investigations, CAPAs, APRs, Minitab, SPC, SAS-JMP/Discovery, SAP, QA, Compliance, Medical Device, Pharmaceuticals, Biotechnology
Engineering Manager - 31 Years of Experience - Near 85224
Engineering project manager with 25 years' experience designing and manufacturing medical devices and 6 years' experience in business ownership and sales. Driver of all aspects of projects from gathering customer requirements to production release. Specialist with Class II and III combination products. FDA-recognized expert with Design Controls. Highly skilled people and situation manager. Leader at coordinating all depart...
Ideal Companies: Medical Device Companies, Employees 0f 100-250
Tags for this Online Resume: Microsoft Windows, Design Controls Expert, Engineering Project Manager, CAPA Investigator, Technical Sales, ISO 13485, ISO 14971, Internal and Vendor Auditor, FMEA, 510(k), Patents
Clinical Research - 17 Years of Experience - Near 92804
Director of Clinical Site Development Offering +15-years' experience of executive level clinical research site and staff development. Highly motivated, solution-focused, and proven leader with in-depth knowledge of industry regulations that govern clinical research. Solid track record of successfully developing elite industry preferred clinical research organizations from conception. Inspirational and innovative leader with...
Tags for this Online Resume: Audit, Leadership, Clinical Research, Research, ISO, Training, Compliance, Management, Procurement, Quality
