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Online Resumes with "CAPA "
Director of Quality
KEY QUALIFICATIONS * Total Quality Management Root Cause/CAPA/ CI Supplier Certifications Project Management ISO 9001, 13485, AS9100 Global Management Program Management Six Sigma, Lean, FMEA
Tags for this Online Resume: Capital Assets, Tape Drives, Project Manager, 5S, Automotive, Banking Industry
Clinical Quality Assurance - 15 Years of Experience - Near 27502
Tags for this Online Resume: Root Cause Analysis, ISO, Corrective Actions, Management, Policies and Procedures, Process Improvement, Quality Assurance, CAPA, Quality, Manufacturing, cGMP, CFR 21, Teamwork, Auditing, Deviation Management, SPE, ASQ CQIA, Calibration/Validation, Product Release, Direct observations, Training, MS Suites, EU Regulations, CLIA
Biomedical Engineer
SUMMARY * Extensive experience in the Pharmaceutical, Biomedical, and Semiconductor industries. * Well rounded Engineering and Business experience in Project and Operations Management, Quality Assurance, Applications, Equipment, Process, and Electronics Engineering. * Data driven, results-oriented, team-builder who strives to make significant, measurable contributions. * Thrives in complex, cross-functional, and dynamic env...
Tags for this Online Resume: Cardiopulmonary resuscitation (CPR), Diagnostic Imaging, Distribution, First Aid, Imaging, ISO, ISO 9001, Medical, NRC, Nuclear Medicine
Quality Systems Specialist - 20 Years of Experience - Near 94545
Summary * Multiple years' experience and thorough understanding of technical and business requirements for Biotech in clinical and commercial multi-product manufacturing facility. * Knowledge of regulatory expectations and requirements for protein purification facilities and industry standards and practices, manufacturing processes, cleaning validation, safety principles, quality systems, cGMPs, engineering design fundament...
Tags for this Online Resume: GMP, Troubleshooting, NPI, Change Control, Data Analysis, Management, Manufacturing, Product Development, Quality, Quality Assurance
Biologist - 13 Years of Experience - Near 07208
Qualifications Summary Highly competent, diligent, and detail-oriented management professional, equipped with extensive experience and expertise focused on various areas of quality improvement, process validation and qualification, manufacturing, risk analysis, as well as implementation of standard procedures and policies within the pharmaceutical industry. Possess solid instrumental analysis skills and expertise in categor...
Tags for this Online Resume: Management, Complaints, CFR Part 11, High Performance Liquid Chromatography (HPLC), FDA, New Jersey, MSDS, Policies and Procedures, Process Improvement, Protocol, CAPA
Biologist - 20 Years of Experience - Near 33543
Tags for this Online Resume: Quality Systems, Pharmaceuticals/Biotechnoogy, Medical Devices, Cytology Lab Supervisor, QA Investigations and CAPA
Operations Manager - 15 Years of Experience - Near 10916
Experienced with Corrective Actions and Preventative Actions (CAPA). Tracked and evaluated incoming and outgoing quality metrics. * Performs root-cause analysis and other problem solving methodologies to identify effective corrective actions and process improvements. * Brought in manufacturing reps to train employees on the use of equipment and/or products. * Wrote work instructions and procedures with documentation for ISO...
Tags for this Online Resume: Management, Manufacturing, 5S, Documentation, Information Technology, ISO, Kaizen, Micrometers, PDF, Quality
Quality Engineer - 10 Years of Experience
Tags for this Online Resume: Protocol, Audit, Manufacturing, Compliance, Troubleshooting, Packaging, Coaching, Management, Plastics, Training, Quality, CAPA, GMP, Supervision
Business Analyst - 17 Years of Experience - Near 11725
SUMMARY Business Analyst / Validation Lead / Specialist / IT/QA Compliance Specialist with Pharmaceutical, IT, Manufacturing and Software QA experience: An IT professional with extensive experience in QA/Compliance, Testing, SQA, PM, Validation and Documentation specialties include: * Business Analyst experience consists of specializing in writing business workflow processes and translating them into Business, Functional an...
Tags for this Online Resume: Compliance, Information Technology, Test, Quality, Training, Good Clinical Practices, HP, ISO, Good Laboratory Practices, Manufacturing
QA - 20 Years of Experience - Near 39426
Pharmacopeia upgrade monograph tests for Dimethyl Sulfoxide. * Monitor and update USOSHA and foreign country SDS sheets and product label / placard required for a wide array of products. * Played an integral role in securing the EU Certificate of Suitability (CEP) for Procipient Dimethyl Sulfoxide in 2014. and Health Canada Drug Master Files (DMF) for Dimethyl Sulfoxide to ensure compliance and enhance clarity. Maintained r...
Ideal Companies: 1 month -
Tags for this Online Resume: Audit, Pharmaceutical, Quality Assurance, Test, DMS, Dms (Data Mgmt Tool), QA/QC, ISO, Management, Instrumentation
Chemical Engineer - 14 Years of Experience - Near 77004
SUMMARY Over 7 years of diversified international experience in the Engineering sector including pharmaceuticals, oil and gas and power plants. Well-qualified to contribute in Pharmaceutical environment from Lab, Pilot Plant to FDA-compliant production. Experienced in both batch and continuous processes. Experienced in execution of validation processes, Temperature Mapping & knowledge in validation testing (IQ, OQ, PQ, RQ, ...
Tags for this Online Resume: IDS, Engineering, Evaluate, Manufacturing, Quality, sheets, Audit, Autocad, Autodesk AutoCAD, Automation
Clinical Quality Assurance
SUMMARY OF QUALIFICAITONS * Global and domestic cGxP operation, quality and packaging experience in medical/precision and diagnostic devices, pharmaceuticals and biomedical industries * Managed Chemistry and Manufacturing Controls: including API sourcing, vender/raw material qualification, formulation, product/process development, scale-up, clinical supplies, technology transfer and validation * Wrote and compiled CMC porti...
Tags for this Online Resume: Cancer, Consumer Products, Engineering, OTC, Process Engineering, Product Development, Risk Analysis, Commercial Production, Team Lead, API
