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Online Resumes with "gmps"



Quality Assurance Director - 11 Years of Experience - Near 44074

SUMMARY OF QUALIFICATIONS OSHA, ISO standards, FDA GMPs, and blood establishment FDA regulations * Microsoft Office * Trainer and public speaker * Hematology, Blood Bank, Chemistry, Serology Testing

Tags for this Online Resume: Chemistry, Instrumentation, Documentation, Good Manufacturing Practices, Management, Manufacturing, Operational Excellence, Quality, Quality Assurance, Root Cause Analysis

Quality Coordinator - 20 Years of Experience - Near 00705

Summary of Over 39 years of successful experience in Quality (Quality Assurance/Quality Qualification Control/Quality Operation) in the pharmaceutical and medical device manufacturing area. Strong knowledge of investigations and CAPA. Excellent knowledge in cGMPs, Incoming inspection, complaints handling, validations, change control, packing material, manufacturing and packaging area. Strong leadership, negotiation, communi...

Tags for this Online Resume: Filing, Management, Packaging, Audit, Injection Molding, Policies and Procedures, Quality, Quality Assurance, Quality Management, Medical, healthcare, Healthcare

Quality Supervisor - 18 Years of Experience - Near 11434

SUMMARY A professional Quality Control and Quality Assurance Engineer/Specialist with 9 years of experience implementing and improving quality management systems/ programs to support Manufacturing, instrumentation, Validation, and processes Quality Management Systems and Information Management Systems Qualification Summary: Quality Assurance (manufacturing) * Experienced in ISO 9001 and ISO 13485 standards to ensure that pr...

Tags for this Online Resume: Quality Assurance, Test, Database, ISO, Management, Manufacturing, Procurement, Quality, Quality Control, Quality Management, manufacturing, production

Microbiologist - 11 Years of Experience - Near 20148

AREAS OF EXPERTISE * Analytical Science * Food Processing * Regulatory Compliance * Molecular biology * GMPs * Team Leadership * Food Safety * HACCP * Laboratory Techniques * Research & Analysis * FSMA * HPLC, UPLC, GC * Food Safety Consultant

Tags for this Online Resume: Research, Communication Skills, Consulting, ELISA, High Performance Liquid Chromatography (HPLC), Product Development, Risk Analysis, Science, Food Microbiology, Molecular biology

Manager - 10 Years of Experience - Near 91387

QUALIFICATIONS * Customer-focused / diplomatic / tactful / positive / upbeat * Superior Manager / coach / trainer / mentor / solution-oriented / highly organized * Persuasive oral / written communicator / high level of motivation / aptitude * Interact well at all levels internally and externally / excellent stability * Adept Team Leader or function well as an individual contributor * Resourceful problem solver / outstanding...

Tags for this Online Resume: Compliance, Distribution, Test, Collection, Team Lead, Customer Service, Flooring, Inventory, Inventory Control, Retail, assistant manager, management

Featured Profile

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

Clinical Regulatory Affairs - 2 Years of Experience - Near 02215

PROFESSIONAL SUMMARY: A Regulatory Project Manager with 2+ years of managing IND/NDA/BLA review processes and 1+ years of cGMPs experience in pharmaceutical industry. Deadline-driven and highly reliable professional, successfully managing over 300 applicants' submissions in IND, NDA, BLA, and BSE as well as participating in 4 cGMPs sponsors' inspections (Japan and Taiwan) and 1 FDA inspection at manufacturing plants. Great ...

Tags for this Online Resume: Compliance, Pharmaceutical, Project Management, Regulatory affairs, CMC, NDA, IND, BLA, cGMP, GCP, ICH

Department Manager - 20 Years of Experience - Near 07660

SUMMARY Trained Raw Material Warehouse Supervisor with 18 years in Pharmaceutical Industry. Seeks employment as Supervisor with a growing company. Results-driven, skilled Warehouse Supervisor focused on achieving success and increased productivity through improvements in operations, quality, safety and administration. Adaptable supervisor familiar with all aspects of logistics, shipping and receiving and general warehouse o...

Tags for this Online Resume: 5S, Communication Skills, Compliance, Housekeeping, Inventory, Leadership, Logistics, Management, Material Handling, Pharmaceutical, SAP, reliability, production, manufacturing

Chemist

QUALIFICATIONS * Ability to participate in development, optimization, and validation of analytical methods. * Project leader: responsibility for projects, e.g. method improvements, implementation of new methods and instrumentation. * Extensive knowledge and skills in telecommunication project management and customer service. * Ability to record, analyze, review data, maintain analytical lab instruments and laboratory suppli...

Tags for this Online Resume: Appraisals, Support, Wireless, Data Entry, Management, QA/QC, AT&T, Ethernet, Internet, OC-3, chenistry

Chemist - 10 Years of Experience - Near 45245

Professional Summary Skills Materials handling correctly by following the work sheet and Controlled the pH, calibration, weighing, diluting, titration environmental compliances. for the finished products. Recorded all operating Data on daily work sheet to create Interpreted results of process control analysis and made and maintain all of the documentation as a reference. adjustments to optimize plant performance. Performed ...

Tags for this Online Resume: Documentation, Microsoft, Occupational Safety and Health Act, OSHA, Process Control, Quality, Quality Assurance, Quality Control, Test, pharmaceutical, production

Production Manager - 20 Years of Experience - Near 32825

PROFILE A strategic results-driven Quality / Validation, Operations, Engineering, and Project Management Professional with more than 15 years of experience in world class Pharmaceuticals and Medical Device industries. Vast experience compliance of cGMPs and associated regulations, investigations and corrective actions (NC & CAPA), remediation's planning/budgeting and execution of commitments to FDA, equipment and facilities...

Tags for this Online Resume: Quality Assurance, Budgeting, Complaints, Compliance, Consulting, Corrective Actions, CVS, Distribution, Engineering, Management

Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry

PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...

Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device