CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "capa"

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

Life Scientist - 20 Years of Experience - Near 30523

QA Manufacturing Compliance Lead Lead QA Validation Remediation - Comprehensive Product and Process gap assessments of HVAC, Utility Maintenance programs, product Scale-up through commercial validation, packaging and manufacturing process failures, and customer complaints for Prescription, OTC & DEA products. Conduct review of CMO validation change control and QC OOS/OOT reports and write annual Product Review for all produ...

Tags for this Online Resume: Training, Project Management, Distribution, Management, Risk Management, CFR Part 11, Design Specification, pharmaceutical, protocol, Leadership, Staff development, cleaning validation, process validation, computerized systems validation, Program Management, QC testing, Chemist, CAPA, NCR, Customer Complaints, Supplier Quality, commissioning, equipment qualification, equipment purchase, Change control, Auditing, Medical Devices class I, II and III, Pharmaceutical development DOE, Pharmaceutical Clinical Scale-up, Mfg./Pkg. Management, ISO13485, Technical Reporting, FDA site QA contact

In Between - 15 Years of Experience - Near 27572

QUALIFICATION SUMMARY Thirty-five years of pharmaceutical/biotech industry biotech with management experience. Able to adapt to rapidly changing business situations and move forward with change while using strong communication skills to facilitate a high level of collaboration among peers and co-workers. Broad background of experience and expertise in the following areas: * Quality Control/Quality Assurance * Team Developme...

Tags for this Online Resume: Training, Corrective Actions, Data Processing, Good Manufacturing Practices, Manufacturing, Quality Assurance, Test, Data Entry, Document Management, Filing

Quality Manager - 17 Years of Experience - Near 30553

To assure quality management system compliance, continuous improvement, manufacturing process efficiency and overall product quality at the management level.

Tags for this Online Resume: ISO/TS16949, ISO9001, Quality Planning & Strategy, Continuous Improvement, Internal Auditing, Process Efficiency, IMDS & Conflict Minerals, APQP/PPAP, Root Cause Analysis, CAPA, IATF 16949, Team Building & Leadership, IATF16949, IMDS, APQP, PPAP

Quality Engineer - 10 Years of Experience - Near 95765

QUALIFICATIONS: Extensive Professional engineering experience in lead-frame manufacturing, PCB Contract manufacturing, Box Build and in the Semiconductor field with proven skills in the following areas: * ISO 9001. IPC 610. ` * Customer & Supplier Interface. Interpret Customer Drawings. * Technical review of customer specifications. RMA, MRB, NCMRs, CAPAs. * Certified Internal Auditor (RAB). GR&R, SOPs * Training Supervisio...

Tags for this Online Resume: ISO, ISO 9001, Complaints, Quality Assurance, Test, Corrective Actions, Management, Process Improvements, Quality, Quality Management, manufacturing, production

Clinical Quality Assurance

SUMMARY * 20+ years of experience in Quality Management and continuous improvement of quality, within Drug Safety, Clinical, Manufacturing, Regulatory Compliance and R &D domains of Bio-Pharmaceuticals * Conducted risk based Investigator site global audits including contract global central clinical labs * Conducted and Managed CRO's, 3rd party vendors / service providers for GCP and GvP compliance * Supported Internal and e...

Tags for this Online Resume: Services, Compliance, Infrastructure, Link Access Procedure (LAP), Research and Development, SDLC, Test, Packaging, Product Development, Quality

QA/QC Manager - 5+ Years of Experience. Worked in Biotechnology, Pharmceutical, Cosmetic and Food Industry for 18+ Year - Near 02919

Professional Summary: Quality Control Manager with 10+ years of experience working in pharmaceutical, biotech, cosmetic and food industry recent experience has been in management roles with concentration on regulatory compliance and project management additional skills include chemistry and microbiology analysis, with strong technical background, effective communication and interpersonal skills, and ability to lead successf...

Tags for this Online Resume: Deviation, Stability, LIMS, HPLC, Wet Chemistry, Raw material, Technical Operation Training and development, Change Control, CAPA, Investigation, Learning Management System, Master Control, SABA, SAP, FDA, USDA, Regulatory Compliance, FDA Audit, Third Party Audit, USDA Audit, Microbiology, Method Transfer, Validation, Bioassay, Elisa

Quality Engineer - 3 Years of Experience - Near 49512

Profile: * Manufacturing quality and systems engineer with experience in high volume environment * Foundation of Six Sigma and Quality improvement certified. * Lean Systems certified. * Working towards attainment of ASQ CQE certification Areas of Expertise: * Six Sigma & Lean methods * 8D /5W/ Root cause analysis * Kaizen, TQM/TPM * Value stream mapping (VSM) * PFMEA / DFMEA * Standard operating procedures (SOP) * GR&R / GD...

Tags for this Online Resume: Quality, Quality Assurance, Accenture FOUNDATION, Apple MacIntosh Operating System, APQP, Autocad, Autodesk AutoCAD, Complaints, Corrective Actions, DFMEA, manufacturing, mechanical engineer, electrical engineer, reliability, "project management", production

Quality Coordinator

SUMMARY Quality Assurance Manager with expertise in pharmaceutical and chemical, quality control and quality assurance areas. Managing and coordinating quality assurance functions of pharmaceutical and chemical industry from inception to completion while communicating horizontally and vertically in a highly regulated FDA/EU environment. Possess a background in both Fortune 500, entrepreneurial and start-up environments. Exp...

Tags for this Online Resume: Complaints, Quality, Quality Assurance, Quality Control, Compliance, Test, Audit, Corrective Actions, DSC, High Performance Liquid Chromatography (HPLC), rn

Clinical Quality Assurance - 15 Years of Experience - Near 03811

Tags for this Online Resume: Complaints, Documentation, Pharmaceutical Industry, Quality, Quality Assurance, Quality Control, Risk Analysis, Test, Compliance, Kaizen, trackwise, batch record review, CAPA, deviations, audit, VEEVA

Supervisr, Reagent process

I am seeking to align myself with a progressive company poised for a strong growth and market expansion. With extensive experience of leading and managing production of Reagent products in cGMP environment ensuring compliance.

Tags for this Online Resume: GMP, Non-conforming, Laboratory experience, CAPA, FDA compliance, Auditing