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Online Resumes with "fda "
Director of Quality - 20 Years of Experience - Near 91325
Summary of Career Milestones: * BS degree in Industrial Technology. Final semester of a combined Masters Program * 25 years in various manufacturing environments including electro-mechanical, medical devices and Aerospace/Defense * Lean Six Sigma Master Black Belt Certified (LSSMBB) (Global Cert - Germany and Villanova University) * Multiple Quality related certifications from ASQ, ASNT, RAB, IRCA, SME. * Certified Internat...
Tags for this Online Resume: Test, Engineering, Reliability, Management, Manufacturing
Chief Executive Officer - 20 Years of Experience - Near 32968
QUALIFICATIONS * Creating High-Performance Teams * FDA 510k Process * Operating Leadership - Accountable * Multimillion-Dollar Resource Management * Innovator - Creating Breakout Growth Plans * Technology licensing & Acquisition * Capital Sourcing, M & A, Roll-ups, Bolt-On's * Non-Profit Executive Leadership * Executable GTM Sales & Marketing Strategies * Mobilization, Donor Development * Agile Software Development Environm...
Tags for this Online Resume: New Ventures, Investor backed, Business Development, Innovator, Call Center, Equity, Equity and Debt, Management, Manufacturing, Product Development
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
Business Analyst - 20 Years of Experience - Near 19454
Summary Information Technology Professional with 25+ years of experience as a project manager, business analyst, and developer in the pharmaceutical and financial industries. Background in system implementations and conversions. Exceptional ability to understand business needs and identify opportunities to improve processes using the appropriate technology. Proven track record of delivering high visibility projects on sched...
Tags for this Online Resume: AutoSys, Brio, Ca7, Cobol Programming Language, Documentation, Enterprise Requirements Planning, ERP Systems, File Transfer Protocol, HyperText Markup Language, IBM DB2 Database, agile, sql
Quality Engineer - 9 Years of Experience - Near 61080
Qualifications: Professional experience in Quality and Manufacturing Engineering, Quality Assurance Supervision. Development and Revisions of Standard Operating Procedures, Work Instructions utilizing Technical Writing skills. Extensive experience in 5s, ISO 9001, 14001 and OHSAS 18001 internal auditing, TS 16949, 8D, APQP, FMEA, TQM, WCM, SPC, 5 Why, PPAP, cGMP-manufacturing environments including FDA, DEA and USDA regulat...
Tags for this Online Resume: Quality Assurance, Test, Automotive, Corrective Actions, Technical Writing, Complaints, Data Analysis, Documentation, Microsoft, Microsoft Excel
Clinical Research - 1 Years of Experience
enthusiastic and adaptable Administrative Management Professional offers Analytical 15+ years of successful performance in research management quality assurance and customer service industries. * Demonstrated success in donor management processes and compliance regulations * Proficient Excel Word Access PowerPoint Outlook * Trained and experienced in FDA regulatory practices and compliance procedures * Trusted to successful...
Tags for this Online Resume: Compliance, Assistant, Coordinator, Data Entry, Documentation, Clinical Research, Support, Compliance
Health Technologist - 0 Years of Experience - Near 11746
SUMMARY Senior Quality and Regulatory professional experienced in high tech and medical device manufacturing industries. Progressive responsibilities in all areas of Quality Systems in the implementation of TQM, SPC, Six- Sigma, re-engineering, Continuous Improvement, Quality function deployment, implementation of FDA-GMP or QSR, ISO-9001, EN-46001, ISO 13485, EC Directives for CE marking on products, Clinical trial and Pro...
Tags for this Online Resume: Management, Medical, Operating Room, Policies and Procedures, Project Management, Rf, Software, Software Development, Surgical, Test
Biomedical Engineer - 2 Years of Experience - Near 98189
Qualifications Business development and financial skills - Good communicator who interacts professionally in corporate environments, represented company in conferences. - Experience in financial analysis for business development and strategy. Working knowledge of Lean Six Sigma strategies. - Good organization skills, with strong management and documentation of information. Interpersonal and team management skills - Extensiv...
Tags for this Online Resume: C Programming Language, Business Development, CAD Tools, Computer Aided Software Engineering, Consulting, Data Analysis, DBMS, Dialysis, Documentation, Engineering
Operations Manager - 20 Years of Experience - Near 21120
SUMMARY OF EXPERIENCE: Results-driven Pharmaceutical Manufacturing and Technology Transfer professional with over 27 years' experience in global pharmaceutical (Ethical and Generic) and personal-care companies. Managed operating efficiencies and quality through strategic planning, partnering, teamwork, and effective problem solving techniques in plant operations that generated significant improvements. Effectively leveraged...
Tags for this Online Resume: Pharmaceutical, Management, Documentation, Medical, Medical Terminology, Occupational Safety and Health Act, OSHA, Pharmacology, Science, Chemistry
Operations Manager - 15 Years of Experience - Near 92107
SUMMARY * U.S. Navy Veteran with a successful track record of managing detailed multiple tasks simultaneously and working well in a fast-paced environment. * Military experience using MRP systems for billing of materials, planning of purchases and tracking to production orders. * Planned, scheduled, coordinated material production start dates, prioritized work-in-process and expedited as needed to meet shipment schedule uti...
Tags for this Online Resume: A+ Certification, Accounting, Billing, Business Development, Calipers, Complaints, Compliance, Customer Focus, D.O.T., Document Control
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
