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Online Resumes with "FDA Regulation"
Quality Assurance Specialist - 20 Years of Experience - Near 48111
Tags for this Online Resume: Assessments, Audit, IaaS, SaaS, PaaS, Infrastructure, Management, Pharmaceutical Industry, Program Management, fda regulations, part 11, Agile, HIPPAA, ISO, Project Management, Quality Assurance Manager, SDLC, Regulations, IT Quality Manager
Sr. Manufacturing Tech with experience in Quality Assurance
SUMMARY * Strong scientific skillset acquired at academic and industry level. * 3+ years' work experience in the US Biotech industry with vast knowledge of GMP, GLP and ISO standards and regulations. * Detail oriented, diligent and ability to work in teams on multiple projects. Familiarity with 21 CFR pertaining to GMP in bioprocessing, GLP, FDA regulations and bioethics.
Tags for this Online Resume: Good Manufacturing Practices, ISO, QA, GMP, cgMP, gcp, biotech, quality assurance, GLP
Quality Manager - 14 Years of Experience - Near 60090
QUALIFICATIONS SUMMARY Quality Manager with strong leadership and relationship-building, strategic planning and people - management skills. Key strength in conducting internal audits and leading external audits. Extensive pharmaceutical and food packaging industries and automotive experience. Extensive knowledge of ISO 9001, ISO 22000/FSSC 22000, GMP, FSQS, HACCP and FDA regulations. Certified Blue Belt More than fifteen ye...
Tags for this Online Resume: Complaints, Manufacturing, ISO, Appraisals, Scheduling, "project management", maintenance, quality assurance
Production Supervisor - 20 Years of Experience - Near 92555
SUMMARY OF QUALIFICATIONS AND SKILLS: * Bilingual- English & Spanish. * Energetic, flexible and dynamic, operates with a high sense of urgency. * Quick learner & Excellent attention to detail. * 25 Years Experience in Medical Devices (Dental Industry). * 25 Years Experience in Medical Devices Under FDA Regulations, (Dental Industry). * Satisfactory written and verbal communication skills. * Excellent interpersonal, time man...
Tags for this Online Resume: Blue Prints, Blueprints, Calipers, CNC, Micrometers, Attention to Detail, Troubleshooting, Bilingual, Coaching, Communication Skills, manufacturing, production, "project management", machine operator
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
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
Clinical Research - 10 Years of Experience - Near 30067
SUMMARY OF EXPERIENCE: Ensuring quality and integrity in the conduct of clinical research studies to comply with standard operational procedures as defined by GCP and FDA regulations. Manage the conduct of clinical trials within the United States and International markets. Responsible for the delivery of high quality data considering resources, time and cost. Therapeutic areas include: * ONCOLOGY * INFECTIOUS DISEASE * CNS ...
Tags for this Online Resume: Clinical Research, Research, Pharmaceutical, phase i, phase iv, phase ii, phase iii, pharmaceutical, regulatory, cro, clinical trials, research, clinical
Biologist - 20 Years of Experience - Near 27302
Summary Results oriented individual with proven ability to learn quickly and implement problem solving methods to meet both product and process demands. Quality assurance professional with twenty three years of proven leadership skills in client management, FDA regulation adherence and defining/implementing quality system management programs. Skilled at recognizing process improvement needs and taking action to ensure FDA r...
Tags for this Online Resume: Audit, Licensing, Management, Pharmaceutical, Quality Assurance, Test, Manufacturing, Documentation, Quality, Quality Management
Pharmacist - 2 Years of Experience
Familiarity with FDA regulations, standard operating procedures (SOPs), good programming practices (GPP). * Utilized MedDRA and WHO-DRUG dictionaries in creating summary tables for Adverse Events and Concomitant Medications respectively.
Tags for this Online Resume: Information Technology, Coding, Data Migration, Distribution, Documentation, Programming, Project Management, Project Manager, SAP, SAS
Quality Manager - 18 Years of Experience - Near 28117
PROFILE Energetic professional with excellent analytical, problem-solving, managerial and communication skills. Process-oriented leader with 17 years of experience motivating and managing cross-functional teams in the areas of Quality Assurance, Process Improvement, and Factory conformance. Would like to apply my managerial, analytical and statistical skills to significantly improve the bottom line. SKILL SUMMARY Strong Int...
Tags for this Online Resume: Process Control, Strategic Initiatives, Trend Analysis, Corrective Actions, Evaluate, Human Resources, Management, Policies and Procedures, Quality, Quality Assurance, manufacturing, Root Cause Analysis, Supervisor, Statistical Process Control, Greenbelt Certification
Medical & Clinical Laboratory Technician - 10 Years of Experience - Near 85207
Tags for this Online Resume: Instrumentation, Inventory, laboratory, FDA Regulations
Biologist
Seeking a position to utilize my knowledge, skills, and abilities in the industry that offers competitive environment, and gain exposure to upcoming technologies while being resourceful, innovative and flexible. Hands-on experience in DNA and Protein isolation, Purification, SDS-PAGE, Cloning, Mammalian Cell Culture, Transfection, HPLC, PCR, RT-PCR, IVD Assay Development, NGS Data Analysis, Western blot, Immunohistochemistr...
Tags for this Online Resume: Documentation, Research, Assessments, CFR Part 11, Chemistry, Distribution, Electrophoresis, ELISA, High Performance Liquid Chromatography (HPLC), Immunization
