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Online Resumes with "FDA Regulations"
Biomedical Engineer - Biomechanical Specialist
Tags for this Online Resume:
FDA Regulations, GMP, mechanical engineering, medical devices, prosthetics, implantable devices
Featured Profile
Smita K B, Verification and Validation Engineer
Tags for this Online Resume:
Softwate testing experience, Exposure to Quality Center, Clear Quest, Doors and My workshop tools, Knowledge of DICOM and HL7, Knowledge of FDA regulations, Knowledge of QTP, Load Runner tools, Experience of creation of Test plan, requirement analysis, test case execution, defect tracking
Quality Assurance Associate Managert
Quality Assurance professional with problem-solving abilities in Pharmaceutical and Biotechnology industries. Primary strengths include US (FDA) 21 CFR, and ICH Q7A Guidance for API Manufacture, Quality Systems development and implementation and strong auditing skills. Introduced and managed electronic document management software including validation, implementation, and maintenance, as well as project team leadership. R...
Tags for this Online Resume:
Quality Assurance, FDA regulations, CAPA, Document Control, Change control
Director of Quality Systems & Scientific Affairs, 20 years experience in food, dietary supplements and cosmetics
Tags for this Online Resume:
CQM-OE ASQ Certified, FDA Regulated Industries, GMP, GLP, SOPs, HACCP Experience , Influencial Leader, Driven by goals, Motivated by results
- Goal-oriented Project & Service Delivery Manager with comprehensive experience managing technical and Business Process Improvement (BPI) projects in various functional areas, across all project phases. - Innovative and strategic thinker recognized for a
Regional Service Delivery Manager outside of Venezuela
Major strengths include strong leadership, excellent communication skills, competent, strong team player, attention to detail, dutiful respect for compliance in all regulated environment, as well as supervisory skills including hiring, termination, schedu
To obtain a position where I can maximize my multilayer of management skills, quality assurance, program development, training experience, customer service, and a successful track record in the Blood Banking care environment.
Ideal Companies: schools, health, hospital, clubs
Tags for this Online Resume:
•Acting Education Manager, American Red Cross, Oakland, CA: 2004 - 2008 •Education Coordinator, CA: 2003 - 2004 •Phlebotomist, CA: 2001- 2003 •Cable Television CATV Supervisor, Core Communication Inc, Sunnyvale, CA: 1998 - 2001 •CATV System Technician, TCI Cablevision Inc, Fremont, CA: 1991 - 1998 •Technician/Day Shift Supervisor, Avantek Inc, Milpitas, CA: 1984 - 1991 •Airport Security Supervisor, Wackenhut, San Jose, CA: 1983 - 1984 •Multi Craft Instructor, APO NY Germany: 1981 - 1983 •Communication Expert, US ARMY, APO NY Germany: 1979 - 1983
Sr. Director/Director Clinical Quality Assurance and Compliance
Over 19 years of Regulatory / Clinical Quality Assurance & Compliance / Auditing experience. Maintain an excellent knowledge base of all applicable Guidelines, FDA Regulations as well as best practices. I have prior interaction with the FDA, and EMEA/MHRA authorities, leading to successful outcomes. I am considered to be a strategic leader and planner effective in a team environment and customer service focused, with exc...
Tags for this Online Resume:
Clinical Quality Assurance, Compliance, Auditor, GCP, Quality Systems, Director
Senior Clinical Research Associatec
To be involved in clinical research
Tags for this Online Resume:
clinical research associate, clinical team leader, senior clinical research associate, monitoring , FDA regulations, Phase 1- IV studies, site selection to site closeout, maintain GCP ICH compliance, GCP ICH compliance
Featured Profile
Head of Stability - 1 year - Valencia, Ca
I am a Food Scientist who has over 5 years of experience working as a microbilogist/chemist in the food industry. For the past year I have been working as the head of stability for Bocchi Laboratories, a health and beauty contract manufacturing company. My goal is to obtain a managerial/supervisory postion for a health and beauty contract manufacturer or pharmaceutical company where I can have the opportuniry to teach, ment...
Ideal Companies: Thibiant International, Cosmetic Laboratories of America, Levlad Inc., Pharmavite, PureTek, Amgen, Baxter, Johnson and Johnson
Tags for this Online Resume:
Stability Chemist, Chemist, Food Scientist, Microbiologist, Proficient in Excel, Head of Stability
Featured Profile
Experienced Validation/Product Development, Investigation Manager (Medical Devices)
To be an active participant in the validation, product development/launch, product improvement, product investigation, product compliance of a medical device or biotechnology related item.
Ideal Companies: Johnson & Johnson, Pfizer, Roche, Abbott, Battelle, University of Virginia
Tags for this Online Resume:
Validation, CAPA investigations, FDA regulated devices, Product Development, FMECA, Manager, Failure Investigations, Data analysis, Plan/Report writing, Process Excellence, Project Management, Policy Development, Procedure Development, Medical Diagnostic Devices
Smita K B, Verification and Validation Engineer
Tags for this Online Resume:
Softwate testing experience, Exposure to Quality Center, Clear Quest, Doors and My workshop tools, Knowledge of DICOM and HL7, Knowledge of FDA regulations, Knowledge of QTP, Load Runner tools, Experience of creation of Test plan, requirement analysis, test case execution, defect tracking
Quality Assurance Associate Managert
Quality Assurance professional with problem-solving abilities in Pharmaceutical and Biotechnology industries. Primary strengths include US (FDA) 21 CFR, and ICH Q7A Guidance for API Manufacture, Quality Systems development and implementation and strong auditing skills. Introduced and managed electronic document management software including validation, implementation, and maintenance, as well as project team leadership. R...
Tags for this Online Resume:
Quality Assurance, FDA regulations, CAPA, Document Control, Change control
Director of Quality Systems & Scientific Affairs, 20 years experience in food, dietary supplements and cosmetics
Tags for this Online Resume:
CQM-OE ASQ Certified, FDA Regulated Industries, GMP, GLP, SOPs, HACCP Experience , Influencial Leader, Driven by goals, Motivated by results
- Goal-oriented Project & Service Delivery Manager with comprehensive experience managing technical and Business Process Improvement (BPI) projects in various functional areas, across all project phases. - Innovative and strategic thinker recognized for a
Regional Service Delivery Manager outside of Venezuela
Major strengths include strong leadership, excellent communication skills, competent, strong team player, attention to detail, dutiful respect for compliance in all regulated environment, as well as supervisory skills including hiring, termination, schedu
To obtain a position where I can maximize my multilayer of management skills, quality assurance, program development, training experience, customer service, and a successful track record in the Blood Banking care environment.
Ideal Companies: schools, health, hospital, clubs
Tags for this Online Resume:
•Acting Education Manager, American Red Cross, Oakland, CA: 2004 - 2008 •Education Coordinator, CA: 2003 - 2004 •Phlebotomist, CA: 2001- 2003 •Cable Television CATV Supervisor, Core Communication Inc, Sunnyvale, CA: 1998 - 2001 •CATV System Technician, TCI Cablevision Inc, Fremont, CA: 1991 - 1998 •Technician/Day Shift Supervisor, Avantek Inc, Milpitas, CA: 1984 - 1991 •Airport Security Supervisor, Wackenhut, San Jose, CA: 1983 - 1984 •Multi Craft Instructor, APO NY Germany: 1981 - 1983 •Communication Expert, US ARMY, APO NY Germany: 1979 - 1983
Sr. Director/Director Clinical Quality Assurance and Compliance
Over 19 years of Regulatory / Clinical Quality Assurance & Compliance / Auditing experience. Maintain an excellent knowledge base of all applicable Guidelines, FDA Regulations as well as best practices. I have prior interaction with the FDA, and EMEA/MHRA authorities, leading to successful outcomes. I am considered to be a strategic leader and planner effective in a team environment and customer service focused, with exc...
Tags for this Online Resume:
Clinical Quality Assurance, Compliance, Auditor, GCP, Quality Systems, Director
Senior Clinical Research Associatec
To be involved in clinical research
Tags for this Online Resume:
clinical research associate, clinical team leader, senior clinical research associate, monitoring , FDA regulations, Phase 1- IV studies, site selection to site closeout, maintain GCP ICH compliance, GCP ICH compliance
Featured Profile
Head of Stability - 1 year - Valencia, Ca
I am a Food Scientist who has over 5 years of experience working as a microbilogist/chemist in the food industry. For the past year I have been working as the head of stability for Bocchi Laboratories, a health and beauty contract manufacturing company. My goal is to obtain a managerial/supervisory postion for a health and beauty contract manufacturer or pharmaceutical company where I can have the opportuniry to teach, ment...
Ideal Companies: Thibiant International, Cosmetic Laboratories of America, Levlad Inc., Pharmavite, PureTek, Amgen, Baxter, Johnson and Johnson
Tags for this Online Resume:
Stability Chemist, Chemist, Food Scientist, Microbiologist, Proficient in Excel, Head of Stability
Featured Profile
Experienced Validation/Product Development, Investigation Manager (Medical Devices)
To be an active participant in the validation, product development/launch, product improvement, product investigation, product compliance of a medical device or biotechnology related item.
Ideal Companies: Johnson & Johnson, Pfizer, Roche, Abbott, Battelle, University of Virginia
Tags for this Online Resume:
Validation, CAPA investigations, FDA regulated devices, Product Development, FMECA, Manager, Failure Investigations, Data analysis, Plan/Report writing, Process Excellence, Project Management, Policy Development, Procedure Development, Medical Diagnostic Devices
Head of Stability - 1 year - Valencia, Ca
I am a Food Scientist who has over 5 years of experience working as a microbilogist/chemist in the food industry. For the past year I have been working as the head of stability for Bocchi Laboratories, a health and beauty contract manufacturing company. My goal is to obtain a managerial/supervisory postion for a health and beauty contract manufacturer or pharmaceutical company where I can have the opportuniry to teach, ment...
Ideal Companies: Thibiant International, Cosmetic Laboratories of America, Levlad Inc., Pharmavite, PureTek, Amgen, Baxter, Johnson and Johnson
Tags for this Online Resume: Stability Chemist, Chemist, Food Scientist, Microbiologist, Proficient in Excel, Head of Stability
Experienced Validation/Product Development, Investigation Manager (Medical Devices)
To be an active participant in the validation, product development/launch, product improvement, product investigation, product compliance of a medical device or biotechnology related item.
Ideal Companies: Johnson & Johnson, Pfizer, Roche, Abbott, Battelle, University of Virginia
Tags for this Online Resume: Validation, CAPA investigations, FDA regulated devices, Product Development, FMECA, Manager, Failure Investigations, Data analysis, Plan/Report writing, Process Excellence, Project Management, Policy Development, Procedure Development, Medical Diagnostic Devices
