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Online Resumes with "regulatory audit"



Clinical Research Associate

SUMMARY: To apply my knowledge of FDA Good Clinical Practice guidelines/ICH guidelines, extensive site/field Clinical Director, Site Lead Study Management, in addition to my experience with various therapeutic areas of medicine, to a position as a Clinical Research Associate. AREAS OF EXPERTISE * Management * Interview candidates and either make a selection decision or recommend individuals for hire. * Able to manage multip...

Tags for this Online Resume: Clinical Research, Research, Accounting, Acquired Immune Deficiency Syndrome (AIDS), Advertising, Amazon Elastic MapReduce, Audit, Basic First Aid, BLS, Budgeting

Featured Profile

Director, Food Services

Dynamic Food Services Director with more than 10 years of facility food service experience. Demonstrated expertise managing demanding departments at multiple sites. Proven experience planning and managing food service operations and meal services, while maintaining a 98% customer satisfaction rating. Pragmatic Director specializing in driving companies to capture, grown and sustain profitability and market share. Skilled at...

Ideal Companies: Sysco, Coca-Cola, Nestle

Tags for this Online Resume: Policies and Procedures, Support, Planning, Purchasing, Financials, Nursing, Management, Budgetary, Patient Care, Procurement

Vice President - 20 Years of Experience - Near 60467

Accomplishments Manufacturing Engineering: Drove the design and implementation of new lean automated manufacturing facilities, including fabrication, powder coating, and assembly operations in support of new product releases. Grew & developed a mature engineering organization to support operational requirements internally including automation, tool design, packaging design, and Tool & Die functions. Defined capacity plannin...

Tags for this Online Resume: Manufacturing, Management, Project Management, Product Development, Engineering, Reliability, Support, Black belt, Compliance, Quality

Featured Profile

Electrical Engineer - 20 Years of Experience - Near 08085

Experienced senior engineer seeking a defining role in a small company startup, engineering project manager in a medium size company, a high technical/commercial position or project manager in an electrical manufacturer/installer, AE

Tags for this Online Resume: HVAC, Distribution, engineering, management, trubleshooting, startup, commissioning, procurement, design specifications, design drawings, field service, equipment selection, vendor selection, consultant, problem solving

Quality Engineer - 10 Years of Experience - Near 00782

PROFESSIONAL SUMMARY QUALIFICATIONS ASQ member, CAPA Expert Certified, CQA, Quality Risk Management - FMEA, Introduction and Internal Auditor for ISO 9001. Knowledge in cGMP Regulations and International Standard (ISO) as 21CFR820, ISO 13485, 21CFR210 & 211, ISO 9001 & ISO 14001. OSHA Rules, Quality Assurance & Control, Manufacturing, Production, Warehouse, Pest Control. Computer skills: Trackwise, SAP, Maximo, LIMS, Visio,...

Tags for this Online Resume: Manufacturing, Documentation, Quality Assurance, CAPA, Audit, Complaints, Investigations, Good Manufacturing Practices, Internal audit, Management, Systems

Manager - 20 Years of Experience - Near 77382

Management position in the area of Regulatory/EHS /Product Stewardship which utilizes my diverse technical expertise and skills. Expertise Project Management Aerospace/ Automotive Qualifications SAP-EHS Planning/Implementation Implementations - PSM/Responsible Care/ISO EHS/Regulatory Auditing/ Training Emergency Management Planning Global Chemical Compliance/Registration Environmental Compliance Long-Term Capital/Demand Pla...

Tags for this Online Resume: Manufacturing, SAP MM module, Aerospace, Management, Compliance, Acquisitions, Audit, Development Activities, ISO, MSDS

Chief Operations Officer - 3 Years of Experience - Near 22039

ACCOMPLISHMENTS Product Development/Management: As the first Product Manager at Compressus, a start-up in the healthcare IT market focused on telemedicine and imaging software, led a market survey to determine that the stated target market was saturated with similar software, but that an opportunity existed to tweak the product and enter the interoperability and workflow niche. Innovated the architecture, managed the develo...

Tags for this Online Resume: Operations, Account Manager, P&L, muti site management, Analytical Skills, data anaysis, Product management, Business Development, Business Management, Business Plan, Business Process, policies, best practices, Cross functional teams, Vice President, Technoogy, Revenue, sales growth, Financial acumen, Revenue and Expense budget management, Staff Mentoring, SLA Management, Customer Satisfaction, Staff Recruting

Quality Manager - 9 Years of Experience - Near 94580

Summary: Dedicated and well-organized, bi-lingual individual with exceptional leadership skills aimed at thoroughly overseeing initiatives related to food safety and hygiene. Extensive background in food safety, quality assurance and sanitation related to Food Safety Modernization Act. Proven track record in coordinating inspections, cleaning and sanitation processes along with ensuring that the facility runs in accordance ...

Tags for this Online Resume: Quality Assurance, Test, Packaging, Audit, Corrective Actions, Quality, Business Intelligence, English Language, Focus, Forklift

Microbiologist - 20 Years of Experience - Near 80503

Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...

Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing

Director - 20 Years of Experience - Near 08520

ACCOMPLISHMENTS * Lead client teams and CDMOs in Product Risk Assessments, EHS Analyses, Regulatory Audits, FDA PAI readiness program, interfaced with US Environmental Protection Agencies for new and updated Air Emission and Wastes Water Effluence permits. Manage OSHA training and audit programs. Reduced product technical and compliance risks while saving safety-related operating cost by reducing planned budget by >10%. Ben...

Tags for this Online Resume: Engineering, Manufacturing, Compliance, ECMS, HVAC, Infrastructure, Material Handling, OSHA, Business Development, Management, director, consultant, regulatory compliance

Executive Vice President - 25 Years of Experience

SUMMARY Results-oriented executive with strong leadership and management experience in mortgage banking, home equity lending and other consumer lending products. Outstanding record of launching and growing businesses, and leading diverse high-performing teams of up to 700 across Sales, Operations and Credit. Areas of expertise include: Sales Management and Marketing * Team Engagement and Development * Process Design and Re-...

Tags for this Online Resume: Management, Banking Industry, Retail, Retail Banking, management

PMO/Project Manager - Financial Services - New York City

A firm believer that PMO’s should be enablers of progress, not a bureaucratic entity that will count, measure anything and everything just because it can be; producing reams of reports that contain pages and pages of “data” as opposed to meaningful “information” for the actual intended audience; imposing an overhead of 7%-10% on otherwise productive Project Management time filling out redundant templates. I have: Introduc...

Tags for this Online Resume: Banking Industry, Commercial Lending, Front Office, Management, Wealth Management, Derivatives, Disaster Recovery, PMP, Project Manager, AML, agile, software, brokerage, capital markets