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Online Resumes with "Corrective Action Preventive Action CAPA "
OPERATIONS / QUALITY ASSURANCE / SAFETY MANAGEMENT
Over 18 years of top performance in optimizing operations for up to 60K+ SF R&D facilities. A peak performer in establishing operational excellence in all facets of pre-clinical studies, encompassing best practices for quality, safety, compliance, and cost control. Adept at managing quality assurance for studies supporting pharmaceutical/biotech regulatory submissions by conducting independent audits, issuing audit reports...
Tags for this Online Resume: Operations Manager, Animal Research, GLP, Safety, Validation, FDA
Regulatory Pharmaceutical Document Specialist and Technical Writer
Brenda is a Technical Writer and Quality Assurance Regulatory Document Specialist with over ten years of experience in the pharmaceutical industry. She has extensive experience with all types of document project work, including writing, editing, formatting. She has experience as a team member for non-conformance investigations (NCs) and Corrective Action and Preventative Actions (CAPAs). Her analytical and research skil...
Validation Consultant/Quality Engineer/QA Mgmt - Biopharmaceuticals/Medical Devices
Seeking Validation/QE/QA Mgmt positions in the Wilson/Raleigh/Greenville NC area.
Ideal Companies: Purdue Pharma, Becton Dickinson, Sandoz, Merck, GSK, Novo Nordisk, Grifols, DSM
Tags for this Online Resume: Validation, QA, SQ, Regulatory, QE, CAPA
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
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
Director
SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...
Tags for this Online Resume: Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, Good Manufacturing Practices
Engineer - 20 Years of Experience - Near 16505-1812
People oriented Engineer with twenty years experience in a Business environment using Lean Manufacturing, Kaizen, Six Sigma, and employing Safety Techniques, and Total Quality Engineering Management in an ISO 9001:2008 Lean Quality Environment. Worked within the Corrective Action Preventative Action (CAPA) System to reduce Supplier Escapes. Utilized the Continuous Improvement tools to improve Internal Processes. Resolved Fi...
Tags for this Online Resume: Manufacturing, Audit, Data Analysis, Product Design, Reliability, Quantify, Quality Assurance, Test, Transportation, Commodities
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
validation/quality/manufacturing engineer
PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...
Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing
Experienced Chemist
● 4+ years Quality Control (QC) testing of both chemical and non-chemical raw materials in manufacturing industries ● Extensive role in both production and technical laboratory settings ● Motivated and ambitious with excellent interpersonal communication, organization skills, relationship management, and presentation skills ● Fast learner with the ability to grasp and put into application new ideas, concepts, methods an...
Ideal Companies: Dow chemical
Tags for this Online Resume: Problem Solver, Team player
