CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "FDA Audit"

Production Supervisor - 20 Years of Experience - Near 08505

PROFILE * Team leader with 21 years of experience in the pharmaceutical manufacturing and R&D product development industry. * Thoroughly dependable, loyal and well organized, detail oriented and mechanically inclined able to take the lead to get the job done. * Proficient and knowledgeable of industry standards, SOP's, GMP's and their practical applications. * Utilizing strong, constructive communication to train and lead t...

Tags for this Online Resume: Manufacturing, Pharmaceutical, Packaging, Compliance, production, reliability, manufacturing

Medical Office Manager - 5 Years of Experience - Near 27502

QUALIFICATIONS: * Promoted to the Senior CRC position as the youngest individual within the organization due to ambition, diligence, a strong team player with the ability to look at the big picture and plan accordingly. * Developed strong CRO/sponsor/vendor relationships, ensuring continuity and open communications through all phases of the trials. * Continuously reached study goals by collaboration with a diverse populatio...

Tags for this Online Resume: Cardiology, Clinical Research, CMA, Communications, Management, Medical, Project Management, Research, Triage, Research Protocols, IRB, Informed Consent, Mentoring

Clinical Quality Assurance - 7 Years of Experience - Near 19468

SUMMARY 20 years of experience in the Pharmaceutical/CRO industry, including 6+ years in Quality Assurance and participation in a spotless FDA audit. Reliable Quality professional who is dedicated to assuring adherence to internal and external regulations.

Tags for this Online Resume: Clinical Research, Document Review, Inventory, Medical, Protocol, Research, Document Management, Management, Audit, Documentum, trial, gcp, ich

Production Manager - 20 Years of Experience - Near 00727

SUMMARY OF QUALIFICATIONS * Fully bilingual (English/Spanish) * 25 years of proven experience in the Manufacturing and Industrial Engineering field. * 24 years of Supervisory experience including exempt and hourly personnel in demanding manufacturing environments up to 125 employees. * Exposure to FDA, EHS, ISO certification and internal audits * Knowledgeable in the application and interpretation of labor laws, both federa...

Tags for this Online Resume: Compliance, Facilitator, Manufacturing, Process Improvement, Bilingual, English Language, Engineering, Industrial Engineering, manager

Production Inspector - 20 Years of Experience - Near 89521

Areas of Expertise * Quality Control/Assurance * QA/ ISO 9001 * Manufacturing Process Testing * Shipping & Receiving Strategic Planning * FDA Auditing * Inventory Control/Tracking * Deadline Management Process Improvement * EPA Auditing * GMP Protocols * Product Development professional exp Quality Lead, Johns Manville undersea oil exploration and Industrial insulation process. Current. Daily sampling of raw material. Respo...

Tags for this Online Resume: Scheduling, Inventory, Inventory Control, Management, Good Manufacturing Practices, Product Development, Test, Audit, Data Entry, ISO, manufacturing, production

Laboratory Manager - 18 Years of Experience - Near 28037

Qualifications Summary Laboratory Manager with extensive experience in regulated pharmaceutical manufacturing and research and development with more than 10 years of management experience. Thorough understanding of regulated Laboratory environments including but not limited to GMP, GLP, GDP and 21 CFR Part 11. Quick learner with proven track record of driving success. Skilled at navigating FDA and vendor audits. Implemented...

Tags for this Online Resume: Project Leader, Project Management, Budgetary, Drafting, High Performance Liquid Chromatography (HPLC), Management, Planning, Rational, White Papers, clinical, phase, trial, gcp, protocol, pharmaceutical, Quality, LC/MS

In Between - 15 Years of Experience - Near 27572

QUALIFICATION SUMMARY Thirty-five years of pharmaceutical/biotech industry biotech with management experience. Able to adapt to rapidly changing business situations and move forward with change while using strong communication skills to facilitate a high level of collaboration among peers and co-workers. Broad background of experience and expertise in the following areas: * Quality Control/Quality Assurance * Team Developme...

Tags for this Online Resume: Training, Corrective Actions, Data Processing, Good Manufacturing Practices, Manufacturing, Quality Assurance, Test, Data Entry, Document Management, Filing

QA/QC Manager - 5+ Years of Experience. Worked in Biotechnology, Pharmceutical, Cosmetic and Food Industry for 18+ Year - Near 02919

Professional Summary: Quality Control Manager with 10+ years of experience working in pharmaceutical, biotech, cosmetic and food industry recent experience has been in management roles with concentration on regulatory compliance and project management additional skills include chemistry and microbiology analysis, with strong technical background, effective communication and interpersonal skills, and ability to lead successf...

Tags for this Online Resume: Deviation, Stability, LIMS, HPLC, Wet Chemistry, Raw material, Technical Operation Training and development, Change Control, CAPA, Investigation, Learning Management System, Master Control, SABA, SAP, FDA, USDA, Regulatory Compliance, FDA Audit, Third Party Audit, USDA Audit, Microbiology, Method Transfer, Validation, Bioassay, Elisa

Clinical Research, San Diego

Clinical Research Associate - San Diego - 12 years of direct monitoring experience in all phases/indications. Permanent or contract, home-based with full office set-up. Expertise in resolving difficult site issues, CAPA and FDA audit resolution.

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)

Senior Oracle Applications Database Administrator

qProfessional Summary: A highly accomplished infrastructure DBA Tech Lead handling Oracle databases and Oracle Applications ERP & EBS from 11 Years, Strong expertise in Oracle databases, Applications E-Business Suite 11i/R12.2 overseeing the streamlined operations of DBA Services. * Oracle Apps Database Lead, having hands on expertise in database & application administration, production support, installations, configuration...

Tags for this Online Resume: Monitoring, Security, Oracle, Oracle 10G, Query, Structured Query Language, Database, Infrastructure, Management, Oracle Database

Microbiologist

A Validation Engineer with proven success working with major pharmaceutical companies and diversified experience across all aspects of the industry: Quality control manufacturing regulatory compliance and multiple departmental operations. Consistently demonstrating a high level of experience in all aspects of the development execution and close out of commissioning/qualification programs using process design documentation p...

Tags for this Online Resume: Manufacturing, Assessments, Automation, Utilities, Microbiology, Protocol, Collection, Documentation, High Performance Liquid Chromatography (HPLC), Marketing Management