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Online Resumes with "CAPA investigations"
Quality Assurance Professional, Tampa
Motivated, personable business professional with 10 years of experience in Quality within the medical device industry. Accustomed to handling compliance and quality support for FDA, ISO13485, MDD, CMDR and JPAL products. Accomplished in Quality System Regulation implementation and improvement activities, auditing, CAPA investigations, root cause analysis, customer complaints, validations and process improvements. Demonstrat...
Tags for this Online Resume:
quality, engineer, quality assurance, biology
Quality Assurance Specialist, Clinical Quality Assurance - 17 years of experience- SQA Active Member
Based on my extensive experience in a variety of Health care and Clinical Research companies, I am confident that I would be a great asset to any organization.
My expertise includes quality review of documents, processes and systems, root cause analysis, and CAPA investigation. In addition, my projects have focused on the development of the internal/external audits and risk assessments, audits of final clinical reports, po...
Tags for this Online Resume:
Quality Assurance, Clinical Research, Pharmaceutical, Blood Banking, GCP, ICH
QA Manager, Boca raton, FL
To obtain a position where my education and experience and previous work history would help the firm. I am knowledgeable and have worked with 21 CFR 11, 210 and 211.I was responsible for all 3rd party audits; was the responsible head for all FDA audits and responses; headed the CAPA and OOS Investigations and was involved with International Regulatory submissions as well as all FDA submissions. I was resopnsible for all OO...
Tags for this Online Resume:
Quality Assurance, Quality Control, Manufacturing, Teaching, Bio-Statistics, Regulatory
Featured Profile
Experienced Validation/Product Development, Investigation Manager (Medical Devices)
To be an active participant in the validation, product development/launch, product improvement, product investigation, product compliance of a medical device or biotechnology related item.
Ideal Companies: Johnson & Johnson, Pfizer, Roche, Abbott, Battelle, University of Virginia
Tags for this Online Resume:
Validation, CAPA investigations, FDA regulated devices, Product Development, FMECA, Manager, Failure Investigations, Data analysis, Plan/Report writing, Process Excellence, Project Management, Policy Development, Procedure Development, Medical Diagnostic Devices
Quality Compliance - 15 Years of Experience
I am seeking to find a role in Quality Compliance / Auditing. I have 15 years of experience in manufacturing industries (automotive and plastic packaging for pharmaceutical industry).
Tags for this Online Resume:
Quality Auditor, CQA, Document Control, Remote, Willing to Travel, ISO 9001, Quality Compliance, CAPA Investigator
Quality Assurance Specialist
Contribute to the success of the company
Tags for this Online Resume:
Quality, Technical , Research, Training, NC/CAPA investigations, Compliance
Quality & compliance professional with 24 yrs of experience
With over 24 years of hands on experience in positions of increasing responsibility in Pharmaceutical, Bio and Medical Devices companies. Areas of expertise includes: Quality and compliance (FDA /21 CFR ,809/ICH, GxP’s), CSV (Part 11 and GAMP5) and Serialization (DSCSA), Technical Support (SME for manufacturing and quality areas), Audit in manufacturing and lab areas. Other Quality areas: revision/approval of SOP and Qualif...
Tags for this Online Resume:
Quality, Compliance , Validation, Qualification, 21 CFR Part 11, Change control, CSV, 21 CFR 210,211, 809
Manager - 13 Years of Experience - Near 46037
Sr. Manager with 5 years’ experience managing individual contributors and supervisors in a global environment
Proven Quality Assurance leadership skills to ensure IT/Lab/Site compliance with internal procedures and regulatory requirements
Demonstrated ability to successfully lead continuous improvement initiatives with effective planning and organization skills
• Lead CAPA Investigations
• Host FDA/CAP/DOH/Client Audits
...
Tags for this Online Resume:
CAPA, 21 CFR Part 11, SDLC, Metrics, FDA, Quality, Validation
Featured Profile
Quality Assurance and Compliance Professional- 15 Years of Experience - Near 91320
Quality Assurance/ Compliance Specialist in pharmaceutical or biotechnical industry where I can apply my background and skills to identify problem root causes and implement corrective actions. Support and participate in internal/external audits.
Ideal Companies: Johnson and Johnson, ECA Medical Instruments, Amgen, Thermo Fisher
Tags for this Online Resume:
CAPA, Lean Green Belt, 5S, DMAIC, Root Cause Analysis, Audit, Continuous Improvement, Operations
Senior Quality Assurance Specialist
Summary of Qualifications Dedicated and solutions oriented professional with 14 years of medical device background mainly in Quality & Compliance * Highly motivated with demonstrated ability to set appropriate and effective priorities and implement decisions to achieve both immediate and long-term goals while managing multiple tasks and completing priorities. * Effective communication and inter-personal skills with all leve...
Tags for this Online Resume:
Quality, Quality Assurance, Corporate Audit, Manufacturing, Raleigh RTP, Compliance, Internal audit, Supply Chain, FDA
Quality Engineer - 14 Years of Experience - Near 01534
Maintain contracted to Gentex Optics - Dudley, MA * Maintain calibration database and run monthly calibration due lists * Coordinate calibration due list internally and with external calibration labs * Perform calibrations on internal optical instruments and standards * Perform internal quality system and process audits maintain logs and files * Perform CA & CAPA investigations and bring resolutions to a close * Coordinate ...
Tags for this Online Resume:
Corrective Actions, Audit, Complaints, Manufacturing, Inspection, Document Control, Micrometers, Quality Assurance, Massachussetts
Experienced Validation/Product Development, Investigation Manager (Medical Devices)
To be an active participant in the validation, product development/launch, product improvement, product investigation, product compliance of a medical device or biotechnology related item.
Ideal Companies: Johnson & Johnson, Pfizer, Roche, Abbott, Battelle, University of Virginia
Tags for this Online Resume: Validation, CAPA investigations, FDA regulated devices, Product Development, FMECA, Manager, Failure Investigations, Data analysis, Plan/Report writing, Process Excellence, Project Management, Policy Development, Procedure Development, Medical Diagnostic Devices
Quality Assurance and Compliance Professional- 15 Years of Experience - Near 91320
Quality Assurance/ Compliance Specialist in pharmaceutical or biotechnical industry where I can apply my background and skills to identify problem root causes and implement corrective actions. Support and participate in internal/external audits.
Ideal Companies: Johnson and Johnson, ECA Medical Instruments, Amgen, Thermo Fisher
Tags for this Online Resume: CAPA, Lean Green Belt, 5S, DMAIC, Root Cause Analysis, Audit, Continuous Improvement, Operations
