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Online Resumes with "TracKWise"
Clinical Research
PROFESSIONAL SUMMARY Persistent, Organized and detailed oriented professional interested to pursue a position as a Clinical Research Associate (CRA) with a pharmaceutical / biotechnology firm where I can utilize my medical and clinical research knowledge along with my strong technical and procedural skills in clinical monitoring to meet the growing needs for clinical trials of new drugs in multiple therapeutic areas. CORE Q...
Tags for this Online Resume: Protocol, Clinical Research, Research, Complaints, Documentation, Interactive Voice Response, MDR, Voice
Clinical Quality Assurance - 17 Years of Experience - Near 27713
QUALIFICATIONS: QA / Quality Oversight, Data Integrity, Investigations, six sigma, CAPAs, TrackWise, Root Cause Analysis (RCA), Technical / Collaborative / Creative Writing, Microsoft Office, Inhalation, Stability, HPLC, Analytical Analysis, Quality Control (QC), Quality Assurance (QA), Audits, cGMP, cGLP, GxP, cGCP, method development/validation, Instrumentation/Automation, software, 21 CFR Part 11, FDA / ISO / Internation...
Tags for this Online Resume: Quality, Investigations, Regulatory, Writer, Raleigh, Data Review, Biotech, Test, Atlas, Automation, Data Entry, Documentation, Manufacturing, Protocol, Quality Assurance
Production Manager - 18 Years of Experience - Near 02725
SUMMARY Eighteen years experience in Manufacturing or Manufacturing support, including over ten years of supervisory experience. Proven ability to drive production against aggressive schedules while rigorously maintaining safety, quality, and regulatory standards. Expertise in training, documentation, and technical transfer functions. Familiarity with Lean Manufacturing and continuous improvement initiatives. Extensive expe...
Tags for this Online Resume: Documentation, Good Manufacturing Practices, Support, Compliance, Housekeeping, Management, Utilities, Evaluate, Kaizen, Lean Manufacturing
Production Manager
Additional Qualifications * Experienced with the following software and systems: MS Office, SAP, Trackwise, Minitab, etc. * Experienced in technical writings such as Work Instructions, SOP's, PPM's, Capital Expenditure Requests, Preventive Maintenance Techniques, Single Point Lessons, Validation Protocols, Demand Flow Technology, etc. Experienced with the following regulations and standards: FDA, GMP, HACCP, ISO 9001, ISO 1...
Tags for this Online Resume: Consulting, Scheduling, 5S, Business Management, Facilitator, Inventory, Management, Process Improvements, Diagnostics, Operational Excellence
Quality Systems Specialist - 20 Years of Experience - Near 94545
Summary * Multiple years' experience and thorough understanding of technical and business requirements for Biotech in clinical and commercial multi-product manufacturing facility. * Knowledge of regulatory expectations and requirements for protein purification facilities and industry standards and practices, manufacturing processes, cleaning validation, safety principles, quality systems, cGMPs, engineering design fundament...
Tags for this Online Resume: GMP, Troubleshooting, NPI, Change Control, Data Analysis, Management, Manufacturing, Product Development, Quality, Quality Assurance
Production Supervisor - 6 Years of Experience - Near 94015
SUMMARY: * Self-motivated and result-oriented MBA-level professional with proven abilities in strategic planning, driving projects, cutting costs, and improving the efficiency of manufacturing operations. * Outstanding leader with excellent collaboration skills, interpersonal skills and experience leading cross-functional teams.
Tags for this Online Resume: Manufacturing, Planning, Scheduler, Forecasting, SAP, Six Sigma Quality, Team Lead, Applications, Bilingual, English Language, MES, EDMS, Trackwise, Leadership, MBA, Warehouse managing, Process Improvement, Cross-functional teams
Not Listed - 20 Years of Experience - Near 07936
SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...
Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist
Marketing - Near 94401
Summary of Qualifications Seeking a position in Medical Affairs/Medical Writing/Regulatory Affairs/Marketing/Publications: * Pharmaceutical, Medical Device, Biotech and High Tech industry management experience and training * Expertise in translating complex technical, scientific and medical information into internal and global customer communications strong client communication skills Experienced with literature reviews, se...
Tags for this Online Resume: Advertising, Management, Project Management, Statistical Analysis, Telemarketing, Billing, Budgeting, Certificate Authority, CMM (Capability Maturity Model), Coding
Quality Engineer - 10 Years of Experience - Near 00782
PROFESSIONAL SUMMARY QUALIFICATIONS ASQ member, CAPA Expert Certified, CQA, Quality Risk Management - FMEA, Introduction and Internal Auditor for ISO 9001. Knowledge in cGMP Regulations and International Standard (ISO) as 21CFR820, ISO 13485, 21CFR210 & 211, ISO 9001 & ISO 14001. OSHA Rules, Quality Assurance & Control, Manufacturing, Production, Warehouse, Pest Control. Computer skills: Trackwise, SAP, Maximo, LIMS, Visio,...
Tags for this Online Resume: Manufacturing, Documentation, Quality Assurance, CAPA, Audit, Complaints, Investigations, Good Manufacturing Practices, Internal audit, Management, Systems
Business Analyst
SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...
Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11
Quality Manager - 14 Years of Experience - Near 00969
Summary of Qualification Electrical Engineer with broad experience in the Electronic, Electro Mechanic and Pharmaceutical Industries. Green Belt and ASQ-CQE Certified, Black Belt Trained. Strong knowledge on CFR, Aseptic Pharmaceutical Manufacturing Process and cGMP. Managed major document types as Annual Product Quality reports (APQRs), Master Batch Records (MBRs), Standard Operational Procedure (SOPs), Stability Studies a...
Tags for this Online Resume: Quality and Compliance, Audit, Budgeting, GMP, REgulatory, Data Management, Documentation, Fabrication, KPI metrics, Leadership, Management, Change Control
Quality Assurance Specialist - 12 Years of Experience - Near 03079
SUMMARY OF EXPERIENCE * Software testing specialist with 12+ years of experience working within computer software industries. * Six years directly related experience as software Quality Engineer in a regulated environment and thorough understanding of QSR/MDR/eMDR requirements and FDA expectations related to software validation of ERP, PLM, QMS applications and systems * Strong domain knowledge on Health Care, Pharmacy, Ret...
Tags for this Online Resume: Applications, Database, Extensible Markup Language (XML), IBM, IBM DB2, IBM DB2 Database, Java Programming Language, Management, Microsoft SQL Server, Regression Testing, validation
