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Online Resumes with "Capa"
Regulatory Affairs Specialist
I am Yashica, working as a Regulatory Affairs Specialist and open for new job opportunities. I possess Masters Degree in Regulatory Affairs and have a working experience of Two Years (Plus a research Experience in Regulatory and Clinical area for two years). I am able to work in a Matrix and fast paced environment where one needs to prioritize the tasks and complete in a timely manner. I have handled projects independen...
Tags for this Online Resume: Regulatory Affairs, CMC, Labeling, Submissions, Regulatory Strategy , Clinical
Clinical Research, San Diego
Clinical Research Associate - San Diego - 12 years of direct monitoring experience in all phases/indications. Permanent or contract, home-based with full office set-up. Expertise in resolving difficult site issues, CAPA and FDA audit resolution.
Quality Manager - 15 Years of Experience - Near 02780
Quality professional - 15 years experience in quality systems and validations for medical devices, biologics, and combination products.
Tags for this Online Resume: Risk Analysis, Test, Packaging, Protocol, Manufacturing, Documentation, Management, Systems Documentation, Compliance, Quality systems
Quality Engineer
ACCOMPLISHMENTS & ACHIEVEMENTS * Researched and budgeted for a vast array of new soldering tips and equipment, microscopes, and specialized lens accessories, and a CMM in order to significantly improve inspection results. Automated SPC measurement systems that resulted in real-time data collection cost savings of $480,000. * Champion of lean six sigma and continuous improvement techniques within Kaizen culture. Became subje...
Tags for this Online Resume: Audit, Legacy, ISO, Management, Procurement, Quality, Quality Assurance, Quality Management, Test, Compliance
Electronics Engineer - 20 Years of Experience - Near 93577
Qualifications: * Strong technical background with hands on NPI manufacturing experience * Very efficient in finding root cause of manufacturing process or yield loss. * Strong project management, analytical skills with ability to manage deliverables and expectations * Proven track record in transfer of new product from design to volume manufacturing * Extensive experience in failure analysis on issue seen in production or ...
Tags for this Online Resume: Failure Analysis, Manufacturing, Reliability, Wafer, Engineering, Product Development, Sustaining Engineering, project engineer, Process improvement, Failure analysis, Quality and yoeld improvement, Product develoment, CAPA, Product sustaining Engineer, Quality Engineer
Production Manager - 20 Years of Experience - Near 32825
PROFILE A strategic results-driven Quality / Validation, Operations, Engineering, and Project Management Professional with more than 15 years of experience in world class Pharmaceuticals and Medical Device industries. Vast experience compliance of cGMPs and associated regulations, investigations and corrective actions (NC & CAPA), remediation's planning/budgeting and execution of commitments to FDA, equipment and facilities...
Tags for this Online Resume: Quality Assurance, Budgeting, Complaints, Compliance, Consulting, Corrective Actions, CVS, Distribution, Engineering, Management
Biological Technician - 18 Years of Experience - Near 02421
SUMMARY Quality Control Chemistry works, Internal/External Audits and Inspection, Maintain Laboratory update with Quality Management. Technical work and knowledge of Biotech/ Pharmaceutical QC/QA system with cGMP and GLP compliance, Practice Quality Management and ICH regulations guided by ISO 9000+. Complete COA for drug product and biologics. Maintain liaison with contract manufacturing (CMO/CTL) Operation and collect bat...
Tags for this Online Resume: CFR Part 11, Inventory, ISO, ISO 9000, Troubleshooting, Audit, Change Control, Chemistry, Documentation, pharmaceutical
Quality Manager - 12 Years of Experience - Near 30017
Career Highlights: Change Agent: Transformed a struggling business unit by using Quality Tools, Kaizen principles and lean initiatives that slashed hourly costs from $120 to $59, boosted on-time delivery from 48% to 96%, increased productivity metrics from 43% to 98% and reduced scrap from $1.65 million to only $225,000-all within 2 years. Quality and Customer Champion: Instituted a CAPA and Quality Control Process Control ...
Tags for this Online Resume: Management, Audit, Inventory, Asset Management, Budgeting, Inventory Control, Inventory management, P&L, Product Development, Quality, manufacturing
Chemist - 20 Years of Experience - Near 84341
Areas of Expertise * Batch Record Review * Transfer of Analytical Data (TAP) * GMP & Regulatory Affairs * Remediation * Process Validation * Deviation Resolution * Lab Environmental * CAPA Investigation * Quality Compliance & Assurance * Product Quality Management * Manufacturing of Sterile and aseptic products * 21 CFR, EU Regulations, and ISO 13485 * Safety and Regulatory Compliance * HPLC for API and Finished Product usi...
Tags for this Online Resume: Manufacturing, Pharmaceutical, High Performance Liquid Chromatography (HPLC), Management, Pharmaceutical Industry, Research and Development, Regulatory Affairs, API, Application Program Interface
Quality Manager - 20 Years of Experience - Near 37064
Manager - Accountable for all aspects of ISO 9001:2008 quality management system and quality control. * Lead a staff of 8 quality professionals provided unprecedented level of service to both internal and external customers. * Developed formal validation and design procedures for medical device components compliant to cGMP. * Led all CAPA (RCCA) efforts. Enhanced successful closure by 70% and strengthened root-causes and tr...
Tags for this Online Resume: Science, Acceptance Testing, Protocol, Quality, Quality Assurance, Test, Manufacturing, Corrective Actions
Manager - 10 Years of Experience - Near 75057
Detail-oriented and hardworking individual with more than 20 years of experience in the Medical Device industry. Highly qualified in Complaint Handling Medical Device Reporting and Post Market Surveillance functions.
Tags for this Online Resume: Administrative Assistant, Call Center Management, Management, Microsoft, Microsoft Excel, medical device, CAPA, complaints, MDR reporting, quality systems, quality audits, data analysis, post market surveillance
Quality Manager - 20 Years of Experience - Near 92886
COVER LETTER: Please find enclosed my personal resume outlining my employment background and experience for the position of Quality Manager. I am seeking a long-term position, one which would allow for professional growth and advancement within the company predicated upon individual contributions made toward company goals and objectives. I am an accomplished, detail oriented Quality professional and have achieved success at...
Tags for this Online Resume: "project management", Quality Control/Assurance Manager, Project Management, Project Manager, ISO, Quality Assurance, Test, ISO 9001, TQM (Total Quality Management), Aerospace
