| Resume alert | Resumes 1 - 10 of 318 |
Supply Chain Medical Biller
Manhattan, NY, 10019
... Well versed initiating, reviewing, and approving the CAPA’s, Investigations, and cGMP Technical Reports Successfully completed, submitted the multiple FTF (NCE-1), NDA projects. Familiar with the principles of Well versed with CAPEX and yearly ... - May 23
... Well versed initiating, reviewing, and approving the CAPA’s, Investigations, and cGMP Technical Reports Successfully completed, submitted the multiple FTF (NCE-1), NDA projects. Familiar with the principles of Well versed with CAPEX and yearly ... - May 23
Quality Assurance Drug Product
Perth Amboy, NJ
... o Implementation, maintenance and trending nonconformance, change control and CAPA systems. o Performed routine inspections and in process Quality assurance (IPQA) test of formulations. Projects: o Formulation and evaluation of Herbal Face mist. ... - May 22
... o Implementation, maintenance and trending nonconformance, change control and CAPA systems. o Performed routine inspections and in process Quality assurance (IPQA) test of formulations. Projects: o Formulation and evaluation of Herbal Face mist. ... - May 22
Project Management Assay Development
Piscataway, NJ
... Performed GEMBA walks and lab walkthrough, created and reviewed Deviations, Change Controls, OOS, OOT, and CAPA. Actively contributed to cross-functional meetings and represented analytical functional area to team. Improved Quality Operation of the ... - May 14
... Performed GEMBA walks and lab walkthrough, created and reviewed Deviations, Change Controls, OOS, OOT, and CAPA. Actively contributed to cross-functional meetings and represented analytical functional area to team. Improved Quality Operation of the ... - May 14
Software Development Management Process
Edison, NJ
... data integrity, continuous improvement process (Agile, Scrums, DevOps & waterfall), Quality testing, Advance knowledge in GxP Regulations, Validation deliverables like SOP, CR, Val Plan, Non-CAPA & building solid reports for senior management. ... - May 13
... data integrity, continuous improvement process (Agile, Scrums, DevOps & waterfall), Quality testing, Advance knowledge in GxP Regulations, Validation deliverables like SOP, CR, Val Plan, Non-CAPA & building solid reports for senior management. ... - May 13
Clinical Research Associate
Montville, NJ
... I created and executed CAPA to completion. Facilitate subject recruitment & participation by way of arranging Ubers to site, and other helpful extras as needed Manage and inventory site-specific IP & ancillary study supplies Proofed & edited CRFs ... - Apr 30
... I created and executed CAPA to completion. Facilitate subject recruitment & participation by way of arranging Ubers to site, and other helpful extras as needed Manage and inventory site-specific IP & ancillary study supplies Proofed & edited CRFs ... - Apr 30
Quality Assurance Regulatory Affairs
Kendall Park, NJ
... • CAPA, ICH Guidelines, and Risk Management ISO 14971 • European, Japanese, Canadian, Russian, and Australian Regulatory Requirements. • Laws and regulations governing Human Research • Regulations for Orphan and Pediatric Drug Development COURSEWORK ... - Apr 29
... • CAPA, ICH Guidelines, and Risk Management ISO 14971 • European, Japanese, Canadian, Russian, and Australian Regulatory Requirements. • Laws and regulations governing Human Research • Regulations for Orphan and Pediatric Drug Development COURSEWORK ... - Apr 29
Production Manager Six Sigma
Clifton, NJ
... Key Achievements: Coordinated cGMP, ALCOA, and CAPA training assessments across 1st and 2nd shifts quarterly and bi-annually. Transformed aspiring team members into accomplished Team Leads within just 6 months through dedicated coaching and ... - Apr 10
... Key Achievements: Coordinated cGMP, ALCOA, and CAPA training assessments across 1st and 2nd shifts quarterly and bi-annually. Transformed aspiring team members into accomplished Team Leads within just 6 months through dedicated coaching and ... - Apr 10
Medical Device Project Manager
Edison, NJ
... • Requirement worked on Scientist Biochemistry, Scientist Biology, Protein Scientist, Microbiology, Research Associate, Lab analyst, Lab Technician, Project Manager, Clinical Trial Manager, Medical Director, Compliance Specialist with CAPA, ... - Apr 08
... • Requirement worked on Scientist Biochemistry, Scientist Biology, Protein Scientist, Microbiology, Research Associate, Lab analyst, Lab Technician, Project Manager, Clinical Trial Manager, Medical Director, Compliance Specialist with CAPA, ... - Apr 08
Product Development Quality Assurance
Irvington, NJ
... Compliance as per the relevant regulations Product Development ICHQ8R2, US FDA, WHO, EMA, MHRA Regulatory submission like CAPA reports, CTDs, monthly updates in inspection report response CAPA writing, Quality Risk Management, Change Control, Root ... - Apr 07
... Compliance as per the relevant regulations Product Development ICHQ8R2, US FDA, WHO, EMA, MHRA Regulatory submission like CAPA reports, CTDs, monthly updates in inspection report response CAPA writing, Quality Risk Management, Change Control, Root ... - Apr 07
Business Analyst Change Management
Iselin, NJ, 07067
... Involved in supporting the CAPA implementation steps. Knowledge of QUMAS Doc Compliance, medical device quality management system (QMS) a regulatory content management for electronic control of all documentation and QUMAS Process Compliance, a ... - Mar 28
... Involved in supporting the CAPA implementation steps. Knowledge of QUMAS Doc Compliance, medical device quality management system (QMS) a regulatory content management for electronic control of all documentation and QUMAS Process Compliance, a ... - Mar 28