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Online Resumes with "CAPAs"



Mechanical Engineer - 20 Years of Experience - Near 98012

Tags for this Online Resume: Quality Manager, Tool Engineering , Catia V5, SolidWorks, AS9100C, ISO2008, CAPA

Quality Control

SUMMARY OF QUALIFICATIONS Quality Systems - Quality Control /Quality Assurance Management of Analytical Laboratories/Quality Audits/Scientific Technical Services Liaison Highly motivated, key contributor in Quality Management and cGMP compliance with more than twenty five years of demonstrated growth and success in scientific applications with Contract Manufacturing Organizations in Quality, R&D and manufacturing. Recognize...

Tags for this Online Resume: Analytical Chemistry, Chemistry, Manufacturing, Research and Development, Commercial Production, Compliance, Packaging, Pharmaceutical, Documentation, Quality, validation, Audits

Quality Systems Manager - 15 Years of Experience - Near 60126

Quality Systems Development |Global Regulatory Compliance | Cross Functional Team Leadership Dynamic Quality Systems Management professional with a proven track record of exceeding goals and developing process improvements within multiple top industries. Specialized in Quality System Development, Code of Federal Regulations, ISO Systems Implementation, Personnel Training and Development and Team Leadership. Successful in ...

Tags for this Online Resume: Pharmaceutical, Management, Project Management, Compliance, Document Management, Process Improvement, Trend Analysis, Assessments, ISO, ISO 9001, quality manager, quality assurance manager, compliance manager, continious improvement, quality systems, quality audit, capa, training, quality systems manager

Quality Specialist – two years of experience – Qualification of raw materials - Quality Assurance – Compliance – Change controls- FDA requirements – SOP’s – cGMP-familiar with CAPA

In my two years of experience at Johnson & Johnson, I have gained vast knowledge about different areas : Quality assurance,Complaince, Procurement and Analytical but my goal is to excel in the field of Compliance/Quality Assurance with high level of persistence

Tags for this Online Resume: Compliance, Quality Assurance, Change controls, Leadership, SOP, Computer

Industrial Engineer - 15 Years of Experience - Near 06422

SUMMARY An analytical, results-driven quality management professional with extensive experience leading quality in Medical Devices, Biologics, Combination products, Pharmaceuticals, 510K and 503B Human drug compounding. Hands-on experience in new product development, design for six sigma, validations (IQ, OQ and PQ), risk management, complaints/post market surveillance, CAPA, auditing, supplier management, cGMP/GLP, as well...

Tags for this Online Resume: Quality Assurance, R&R Report Writer, Test, Quality, Assessments, Complaints, Troubleshooting, ISO, Medical, Medical Devices, Quality ASssurance, Medical Device, ISO, 503B, Complaints, Design Control, Quality,

Quality Coordinator - 3 Years of Experience - Near 20874

SUMMARY Objective To pursue a career in a health care organization that offers many challenges and opportunities to make use of academic and professional skills and gained experience to obtain a reputation that can be maintained forever. Experience summary Total Industrial experience - 3+ Years in "BHARAT BIOTECH Ltd"- a manufacturing company for vaccines and bio-pharmaceuticals. Worked from entry level (trainee) to being p...

Tags for this Online Resume: Adobe, Adobe Acrobat, Analytical Skills, Audit, Documentation, ELISA, Firepond Converse, Information Technology, Leadership, Linux, Technical writer, CAPA, Deviation, Documentation control

Clinical Quality Assurance - 20 Years of Experience - Near 46360

Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...

Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance

Process Engineer - 15 Years of Experience - Near 55376

To benefit an organization that can use a knowledgeable Six-Sigma Black Belt Quality Manager with a proven ability to continuously improve processes/customer satisfaction and supplier development while building a strong project team, and strengthen customer relation using various Six-Sigma/Project Management tools and methodologies. Responsibilities: ISO 13485, 14971 Managing/Directing quality staff. Supervising/ Mentoring ...

Tags for this Online Resume: Audit, Data Analysis, CMM (Capability Maturity Model), Management, Product Development, Reliability, Stents, Heat Treating, Plastics, Msa (Accounting Pkg)

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

Clinical Quality Assurance - 20 Years of Experience - Near 19021

SUMMARY OF QUALIFICATIONS: Capable and accomplishment driven individual, with over 20 years of experience in the Pharmaceutical / Drug Development Industry. A flexible problem solver with excellent written and interpersonal communication skills and a dependable team member at both associate and management levels with recognized achievements in the following areas: * Operational experience and management in Primary and Secon...

Tags for this Online Resume: Compliance, Packaging, SharePoint, Sharepoint Technologies, Data Entry, Management, Project Management, Capital Assets, Assessments, Audit, physical therapist, pharmaceutical, trial, clinical

Quality Assurance Director - 20 Years of Experience - Near 92336

A successful Documentation Control Management professional with over 30 years of experience in the Pharmaceutical and Medical Device industry. Excellent communication and interpersonal skills. Committed to motivating and empowering employees to consistently meet or exceed customer expectations and business needs with the following experiences: Quality Management Systems (QMS) development and implementation (QMS was based on...

Tags for this Online Resume: Documentation, Management, Project Management, Pharmaceutical, documentation control, documentation management, quality systems

Clinical Quality Assurance - 20 Years of Experience - Near 19713

AREAS OF EXPERTISE * Quality Assurance, CAPA * Regulatory Stability Documentation * Quality Systems * Strategic Project & Team Management * Troubleshooting / Problem Solving * Stability protocols, SOP's * USP, BP EUP, JP * FDA and ICH guidelines * Chromatographic Data Systems * Method validation and metrics * Lab Inspections & Evaluations * Product Support / Quality Control * Standard Operating Procedures

Tags for this Online Resume: Stability, Quality Assurance, Data Management, Quality Control, Data Analysis, LIMS, Reference Standard, COA Management, FDA and ICH Guidelines, USP,EUP,BP,JP, HPLC, GC etc., pharmaceutical, protocol, ich