CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "CAPA Investigations"

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

Quality Manager - 20 Years of Experience

Summary Over 20 years' experience in a medical device industry. Out of the box thinker who is self-managed, self-motivated, results oriented, quality conscious, problem solver, with ability to multi-task, make decisions, resolve issues, meet deadlines learn new skills and communicate effectively at all levels of the business. Experienced in the following: Receiving Inspection, Final inspection, internal auditing and supplie...

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Angioplasty, Internal Auditor, Good Manufacturing Practices, Manufacturing, Project Coordinator, Test, Green Belt

Quality Assurance Director - 20 Years of Experience - Near 33545

BSI ISO 13485:2003 Lead Auditor (TPECS) Certification - Certificate: 7930649-76913 * Hired and entrusted by B Braun McGaw of Puerto Rico and LeMaitre Vascular to implement a wide-array of corrective actions and systems resulting from 3 FDA warning letters. Subsequently after new systems implementation received 0 FDA 483 observations for a combined period of 12 years. * Built company-wide shared quality visions which complet...

Tags for this Online Resume: Documentation, Quality Assurance, Compliance, Pharmaceutical Industry, Quality, Quality Control, Regulatory Affairs, Medical Devices, Pharmaceuticals, Regulatory Compliance

Quality Engineer - 20 Years of Experience - Near 00704

Possess over twenty (20) years of experience in the pharmaceutical, medical devices, biotechnology and manufacturing industries. Directly involved with Manufacturing Projects. Expertise in Investigations associated to process improvements. Experience in CAPA Investigation, Change Control, and other quality systems. Possess strong expertise from Analytical Laboratory Environment. Strong experience and expertise working in t...

Tags for this Online Resume: Budgeting, Client/Server, Control Systems, Cost Control, Data Management, HVAC, Information Technology, Infrastructure, IT Management, Local Area Network, manufacturing, "project management", Quality Systems, CSV Methodology, PLC/HMI, CAPA, Risk Management, Laboratory Software's Val., LIMS, FDA Regulations / Inspections

Microbiologist - 9 Years of Experience - Near 28704

To become a member of a quality driven team Over 9 years in Quality Assurance/control, 3+ years in a supervisory position of multi-functional teams with up to 16 direct reports within the microbiology lab. Experienced in team building, protocol design and execution, CAPA investigations, Environmental monitoring, endotoxin screening and bioburden.

Tags for this Online Resume: Manufacturing, Plating, Quality, Quality Assurance, Quality Control, Spectrophotometer, ISO, SAS, Microbiology, Internet, protocol, sas, pharmaceutical, environmental monitoring, supervisor

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

Engineering Manager - 14 Years of Experience - Near 92563

Career Summary My current job is Verification & Validation (V&V) Manager for UNICO Engineering for the California High-Speed Rail project. I am responsible for the requirement database, V&V status reporting, and requirements traceability and management for California Rail Builders. I also possess considerable experience with ISO 13485-QMS for medical devices standard and ISO 1497-medical device risk management. My backgroun...

Tags for this Online Resume: Account Manager, Logistics, Quality Assurance, Test, Acceptance Testing, Integrate, Manufacturing, Assessments, Critical Care - Vascular, Green Belt, siemens

Biomedical Engineer - 14 Years of Experience - Near 92563

Career Summary My current job is Verification & Validation (V&V) Manager for the California High-Speed Rail project. I am responsible for managing the requirements database, V&V status reporting, and requirements traceability for the California Rail Builders. I possess considerable experience with ISO 13485 Quality Management System for medical devices standard and ISO 14971:2012 Medical Device Risk Management. My backgroun...

Tags for this Online Resume: ISO, Acceptance Testing, Account Manager, Integrate, Logistics, Manufacturing, Services, Test, Assessments, Critical Care - Vascular, electronics, Metrology

Engineer - 14 Years of Experience - Near 92563

Ideal Companies: Boeing, Northrop Grumman, General Atomics

Tags for this Online Resume: Account Manager, Logistics, Quality Assurance, Test, Acceptance Testing, Integrate, Manufacturing, Assessments, Critical Care - Vascular, Green Belt