CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "FDA Regulations"

Pharmaceutical Professional

To obtain a rewarding position within a pharmaceutical Quality Assurance or Quality Control department, utilizing my unique background to make significant contributions to the organization. Areas of expertise include; FDA Regulation and Compliance, Internal and External Auditing, Pharmaceutical Manufacturing, Quality Assurance, Quality Control, and Laboratory Management.

Tags for this Online Resume: Quality, Pharmaceutical, Quality Assurance, Quality Control, Laboratory, Manufacturing

Able Seamen - 19 Years of Experience - Near 35242

SUMMARY Equipped with an extensive experience to lead, motivate, and align people and processes to turn around failing situations to deliver continuous business results. I possess 10+ years in warehouse management (union and non-union environment) 5 years production plant management experience, strong budget management experience 15+ years' experience with warehousing equipment and supply chain management systems such as SA...

Tags for this Online Resume: Leadership, Management, Business Plan, Training, Manufacturing, Six Sigma Quality, Logistics, Automation, Budgetary, Complaints, Distribution Center Manager, Operations Manager, Supply Chain Manager, P&L, Budgeting, Lean Six Sigma, Continuous Improvement

Quality Assurance Specialist - 6 Years of Experience - Near 75093

SUMMARY * Experienced with Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). * Experienced in Agile and Waterfall environments. * Experienced in using HP interactive products like -HP Quality Center (ALM/QC) and JIRA. * Good exposure to Web technologies like HTML, XML and JavaScript. * Experience in SQL queries and Joins (Inner/Outer) to validate data. * Experience in IVR/IWRS Testing. * Experie...

Tags for this Online Resume: Management, Oracle, Regression Testing, System Testing, Test, Software, JIRA, Microsoft, Microsoft ASP.Net, Microsoft SQL Server, sql, java, javascript, agile, html, software

Supervisor

Mr. Thomas M. Golden is a Senior Validation Engineer with 25 years of experience in the pharmaceutical and biotech industries. Mr. Golden has extensive experience in both management and team player roles in utilities process development scale ups technology transfer cGMP GDP SOPs FDA regulations and critical utilities. He has excellent oral and written communication skills and is an innovative leader who believes in teambui...

Tags for this Online Resume: Manufacturing, Procurement, Utilities, Packaging, Protocol, Acceptance Testing, Management, Pharmaceutical, manager

Quality Manager - 19 Years of Experience - Near 34771

Profile A self-motivated and organized professional with over nineteen years' experience in FDA regulated pharmaceutical, biotechnology, and medical device industries.

Tags for this Online Resume: Consulting, Pharmaceutical, Microbiology, Assessments, Attention to Detail, Bilingual, Biotechnology, Corrective Actions, manufacturing, production, "project management", reliability, investigation, validation, cleaning, ISO, cleanroom

Facilities Manager - 17 Years of Experience - Near 18017

Summary: Management Administration * Analyze annual needs, create forecasts, and set quotas * Perform financial analysis on capital purchases * Fleet and Facility Management * Recruit, hire, and train new personnel * Budget administration, inventory control, and purchasing of supplies * Maintain positive customer and vendor relations * Maintain quality practices while assuring conformance of all activity with company, AABB,...

Tags for this Online Resume: Project Management, Project Manager, Pricing, Distribution, Inventory, Satellite, Advertising, Budgeting, Communication Skills, Financial, building maintenance

ERP - 20 Years of Experience - Near 47630

Summary of Experience and Qualifications * SAP Transformation professional with more than ten years of SAP experience (3 full life cycles), in Consumer & Pharmaceutical Products * Strong Project Management experience in managing multiple medium to large SAP projects ($1 million - $4.5 Million), forming & performing large teams through various stages * SAP Max Attention management, SAP custom engagements: o Success Factors, ...

Tags for this Online Resume: Software, Application Architecture, Management, Pharmaceutical, Business Management, software, SAP, HANA, CONSUMER PRODUCTS

Chemist - 20 Years of Experience - Near 02467

PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities

Quality Assurance Specialist - 7 Years of Experience - Near 75093

Professional SUMMARY * Over all 7 years of experience in the IT industry in Quality Assurance using Web based and Client/Server applications. * Knowledge of Healthcare, Pharma, Security and Biometric projects. * Key expertise includes testing Extensive experience in Manual and Automated testing using Selenium and defect tracking tools like HP Quality Center (ALM/QC), Bugzilla, JIRA and Bug Zero. * Conversant with all phases...

Tags for this Online Resume: Management, Oracle, Regression Testing, System Testing, Test, Software, JIRA, Microsoft, Microsoft ASP.Net, Microsoft SQL Server

Clinical Quality Assurance - 20 Years of Experience - Near 19021

SUMMARY OF QUALIFICATIONS: Capable and accomplishment driven individual, with over 20 years of experience in the Pharmaceutical / Drug Development Industry. A flexible problem solver with excellent written and interpersonal communication skills and a dependable team member at both associate and management levels with recognized achievements in the following areas: * Operational experience and management in Primary and Secon...

Tags for this Online Resume: Compliance, Packaging, SharePoint, Sharepoint Technologies, Data Entry, Management, Project Management, Capital Assets, Assessments, Audit, physical therapist, pharmaceutical, trial, clinical

Plant Operator - 20 Years of Experience - Near 01510

SUMMARY Technical leader with extensive experience in an cGMP FDA regulated industrial manufacturing setting. Committed to safe work practices, quality systems, customer service and compliance for the support of operational activities. Proactive, accountable and collaborative team player. Active member of many highly successful cross functional teams. Proven ability to prioritize and coordinate effectively. ACCOMPLISHMENTS ...

Tags for this Online Resume: Documentation, Automation, Compliance, Customer Service, Lean Manufacturing, Management, Manufacturing, Power (Os Enhancemnt Tool, Preventive Maintenance

Chemist

Responsible for training and mentoring junior chemist to perform complex testing of raw material by GC/MS. Effective organizational skills ability to multi-task and coordinate multiple activities. Performed instrument analytical method troubleshooting and problem solving. Knowledge of FDA regulations and compliance. Participated in Laboratory Investigations and Data Review. Interfaced with R&D and manufacturing department b...

Tags for this Online Resume: Manufacturing, Kaizen, Quality Assurance, Test, Forklift, Quality, Quality Control, Transmissions, Automotive, Documentation