CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "trackwise"

Quality Coordinator - 15 Years of Experience - Near 46163

SUMMARY OF THERAPEUTIC EXPERIENCE Autoimmune Endocrine Neuroscience Oncology Ophthalmology Pediatric Studies Urology Women's Health SUMMARY OF PHASE EXPERIENCE Phase II Phase III Phase IV Device Studies SYSTEM EXPERIENCE: TransCelerate TrackWise OneNote Microsoft Lotus Notes

Tags for this Online Resume: Management, Project Management, Protocol, Quality, Quality Assurance, Risk Management, healthcare, pharmaceutical, data quality

Quality Engineer - 20 Years of Experience - Near 92507

Personal Summary Extensive experience in Medical Device manufacturing (over 27 years) Worked with Pharmaceutical manufacturing industry (5+ years) Opened and reviewed complaints, performed investigative actions for submittal. Effectively work with cross-functional teams. Perform complaint investigations and reviews. Run root cause analysis, identification and implementation of CAPAs. Experienced with FDA auditors. Perform t...

Tags for this Online Resume: Quality Assurance, Documentation, Manufacturing, Pharmaceutical, Reviews, Compliance, ISO, ISO 9000, Packaging, ISO 9001, manufacturing, steel, production, quality

Quality Engineer - 15 Years of Experience - Near 10312

Summary of Qualifications * Provide validation services for pharmaceutical clients to be compliant with FDA regulations utilizing CSV methodology * Professional with a strong background in validation, quality, information technology, and chemistry domains for pharmaceutical and medical device industry * Proven knowledge of FDA regulatory requirements, including cGxP, GLP, GMP, Sarbanes-Oxley (SOX), 21 CFR 210/211, 21 CFR 58...

Tags for this Online Resume: Services, Data Migration, Legacy, Quality Assurance, Assessments, Audit, Management, Quality Management, Pharmaceutical, Quality, validation, CSV, business analyst

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

Not Listed - 14 Years of Experience

Professional Qualifications "Foro de Calidad Regulatoria" (2014) * Training of Structured Problem Solving and Investigation Report Writing Effective Check, Caguas, PR (2014) * Training to Certify Quality Auditor (ASQ), Guaynabo, PR (2013) * "Mejorando tus Auditorías Internas", Caguas, PR (2012) * Train the Trainer Certification, Caguas, PR (2012) * First Aid Certification, Caguas, PR 2012 - 2016 * CAPA Certification, Caguas...

Tags for this Online Resume: Chemistry, Hazardous Waste, Instrumentation, Millenium (Sw-Fin/Admin), Millennium, pH Meter, Quality, Quality Assurance, Quality Control, SAP

Not Listed - 20 Years of Experience - Near 07057

Professional Summary An administrative professional with expertise in several varied business disciplines. Has executed diverse rolls in corporate security, logistics and supply chain security, human resources and benefits administration as well as general managerial support developing and implementing policy and detailed, specific procedures. Customer focused, organized and efficient able to deal effectively with sensitive...

Tags for this Online Resume: PeopleSoft, Security, Compensation, HR, Human Resources, Typing, Support, Benefits, Benefits Administration, Cobra, human resources, hr, customer service, honeywell

Biological Technician - 3 Years of Experience - Near 94303

Summary: Experienced commissioning engineer with over 12 years of practical experience in biotech. Proficient with most equipment related to cell culture fermentation, and oral solid dose pharmaceutical manufacturing facilities. Very strong in GMP documentation FDA, ISO 9000, cGMP, CFR title 21 and DEA regulatory compliance. Familiar with LIMS, BMS, Trackwise, Faciliworks, Word, and Excel.

Tags for this Online Resume: Documentation, Automation, Honeywell, Schematics, Pharmaceutical, Science, BMS, Compliance, Good Manufacturing Practices, ISO, Validation

Biologist - 15 Years of Experience - Near 00778

SUMMARY OF QUALIFICATIONS Sixteen years' experience in the Pharmaceutical & Biopharmaceutical Industry as Senior Manufacturing Associate. Three Years as Active Manager. New Drug Transfer and Validation experience. Bilingual with effective verbal and written communication skills. Experience in managing multiple, competing priorities in a fast paced environment. Computer literate in Windows, Outlook, Power Point, Auto Cad, Re...

Tags for this Online Resume: Manufacturing, Documentation, Packaging, Pharmaceutical, Utilities, Automation, Bilingual, Biotechnology, CAD Tools, Change Control, Validation, Quality

Technical Writer, Philadelphia metro, NYC, Connecticut, New Jersey

I am equipped with 25+ years of experience in Documentation Design/Development and Technical Writing. I am currently exploring gainful opportunity prospects in Pharma and Bio Research. * Analytical and detail-oriented Technical Writer, with vast experience in technical documentation development across various industries. Strong background in writing with superb written communication skills. Expert knowledge in document life...

Tags for this Online Resume: Documentation, Manufacturing, Validation, Technical Writer, Microsoft Excell, Change Control, Microsoft Office, Microsoft Visio Professional, Microsoft Word, GMP

Operations Manager - 19 Years of Experience - Near 00705

Profile Self-motivated professional with eighteen years of combined experience in integrated facilities management, fire protection, life safety, loss prevention consultation, medical devices among other engineering and manufacturing fields. Supervision of small and large group of personnel. Strong analytical, follow through and problem solving skills, team player and able to operate under changing environments. Fully bilin...

Tags for this Online Resume: Manufacturing, Quality, Quality Assurance, Quality Control, Insurance, Product Liability, Security, Troubleshooting, Assessments, Medical, "project management", manufacturing, production, mechanical engineer, maintenance, reliability

Software Engineer - 6 Years of Experience - Near 55404

Professional Summary: * Currently Working as Data Architect/Modeler/ETL consultant/Data Analyst in Wipro Technologies. * Overall 10+ Years of varied experience in IT in Database working knowledge of Retail and Health care. * 4 years of experience as Data architect and Data Modeler (Erwin and Power Designer) in oracle 10 and 11g. * 6+ years of experience of as technical lead for Development teams including the roles of oracl...

Tags for this Online Resume: Oracle, Oracle 10G, Services, Structured Query Language, Management, Microsoft SQL Server, Toad, Crystal Reports, Pharmaceutical, Remedy, Data Architect

Production Supervisor - 7 Years of Experience - Near 64504

QUALIFICATIONS * Proactive and results-oriented pharmaceutical manufacturing and production supervisor with 14+ years of experience overseeing all teams and operations to ensure accuracy, quality, and safety within high-volume, challenging pharmaceutical manufacturing. * Efficient prioritizing, organizing and multi-tasking skills developing process improvements, implementing new procedures, focusing on safety, and implement...

Tags for this Online Resume: Scheduling, Reviews, Training, Management, pH Meter, Spectrophotometer, Corrective Actions, Inventory, Manufacturing, SAP