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Online Resumes with "CAPAs"
Biomedical Engineer - 3 Years of Experience - Near 07470
Tags for this Online Resume: qme, lean sigma, CAPA, Risk analysis, Audit, Biomedical Industry, Quality controlengineer, Data Analysis, CAD, Enterprise Requirements Planning, QSR ISO regulatins
Experienced Director of QA/Validaiton - 15 Years of Experience - Near 27587
Tags for this Online Resume: Validation, Software Validation, GMP, 21CFR, 21CFR PART11, Aseptic Processing,, CAPA, Quality Systems Management, Change Control, Compliance Enhancement, Warning Letter Remediation, Deviation/Exception Management,
Medical or Health Services Manager - 10 Years of Experience - Near 07436
Professional Summary * Detailed clinician with over 10 years Medical Technologist experience performing complex detailed testing in a clinical research laboratory setting. Investigator initiated research projects with compliance background. * Skilled Pharmacy Technologist with over 10 years' experience in pharmacy leadership, technology, and drug development * Diligent, accurate and reliable Laboratory Technologist with a r...
Tags for this Online Resume: ELISA, Protocol, Cardiology, Compliance, Critical Care - Neurology, Critical Care - Vascular, Data Analysis, Good Clinical Practices, Insulin, Management
Vice President - 20 Years of Experience - Near 33076
VP / Director – Global Operations, Quality, Supply Chain or Programs
Tags for this Online Resume: Due Diligence, Supply Chain, Distribution, Manufacturing, Program Manager, S&OP, ERP, CRM, Strategic Deployment, NPD/I, Global commercialization, Financial Management, Lean (TPS), Six Sigma, OPEX, QMS, CAPA Management, FAA, FDA, DFx, Change management, organizational development, Multi-site Inventory & Facilities, M&A, Life Cycle Management, Design Control
Microbiologist - 20 Years of Experience - Near 80503
Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...
Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing
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 Manager - 3 Years of Experience - Near 46390
Hard working and passionate business graduate that thrives on helping others and businesses to succeed. Moving back to Northeast Indiana.
Tags for this Online Resume: Calipers, Complaints, Quality Assurance, Scheduling, Test, 5S, Defense, MSI, Packaging, manufacturing, production, "project management", reliability, CAPA reports, Customer Service
Biologist - 15 +Years of Experience - Near 33759
PROFESSIONAL PROFILE Solid experience in QA Regulatory Compliance world class companies. Interested in a challenging position with focus in QA Systems and Manufacturing operations fields. Broad knowledge in cGMP, ISO, EPA, DOT, FDA, and ANSI ASQC regulations. Working knowledge in sampling, inspection, and disposition processes, SPC, Change Controls, NC/CAPA, Validations, and Calibration systems. Highly organized, enjoy cha...
Tags for this Online Resume: Compliance, Documentation, Packaging, SPC, Test, Management, Quality, Quality Assurance, Quality Management, Assessments, pharmaceutical, sap, protocol, SOP, Validation, NC, CAPA, Change Control, Regulatory, Audit, GAP Assessments, Calibration, Raw Material, Incoming Inspection, Batch REcord Review, Classified Clean Rooms, Investigation Reports, Disposition, REserve Samples Program
Quality Assurance Director - 17 Years of Experience - Near 03062
SUMMARY A resourceful, determined and results driven global quality assurance & regulatory affairs leader with 17 years of experience in R&D, internal & contract manufacturing operation (CMO), supporting domestic & international markets.
Tags for this Online Resume: Product Development, Engineering, Management, Manufacturing, Reviews, Risk Management, Kaizen, Regulatory Affairs, Automation, Compliance, compliance, ASQ, ISO 13485, Design Control, CAPA, Quality Management System, 510k
Biologist - 7 Years of Experience - Near 91346
SUMMARY As a Quality Manager, my job is to ensure the quality of our product. Without controlling the quality of our product, there is no product. My skills and abilities are the following: strong knowledge of ISO, GMP, GDP, SOP, and GLP ~7 years of quality systems and quality oversight calibration of medical devices to ensure validation controlled temperature chambers (CTC) raw materials handling and testing ~5 years of ou...
Tags for this Online Resume: Inventory, Microbiology, Payroll, Chemistry, Media Preparation, Documentation, Quality Oversight, Quality Management, Supervise, FDA, GMP, EMA, GDP, Compliance, Raw Materials, Quality Assurance, Quality Control, Sampling, Audits, Biology, Human Factor VIII, QCA, Biotechnology, Pharmaceutical, GLP, ISO, CAPA
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
Department Manager - 12 Years of Experience - Near 27592
"james.holland68@yahoo.com" Leader and director for Lean Six Sigma program driving Lean deployment, recruiting, authoring annual planning utilizing lean road maps and business cases, maintaining budgets, teaching lean principles, communicating business results via presentations, coaching, hands-on support, and program administration. Supported 14 distribution centers (supply chain), 6 plants, corporate quality, clinics, and...
Tags for this Online Resume: Inventory, Supply Chain, 5S, Kaizen, Management, Root Cause Analysis, 3PL, Annual Planning, Automation, Black belt
