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Online Resumes with "FDA Compliance"
Summary * Experienced Quality Assurance scientist in the pharmaceutical and biotechnology industry working for over 17 years in a cGMP and GLP regulated environment. * Lead efforts in the business analysis for the group's business continuity program and the implementation of the Laboratory Information Management Systems (LIMS). * Knowledgeable in Project Management methodologies like 5S, LEAN and Six Sigma. * Skilled in ana...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Microsoft, Microsoft DOS, Microsoft Windows, Applications, Benefits, Business Analysis, Business Analyst, Documentation, Information Technology, pharmaceutical, sap
I am seeking to align myself with a progressive company poised for a strong growth and market expansion. With extensive experience of leading and managing production of Reagent products in cGMP environment ensuring compliance.
Executive MBA with a doctorate in Chemical Engineering with over 16 years of experience in the development and management of pharmaceutical operations. Expertise in creating operating processes, protocols, policies and technologies to support new drug manufacturing and marketing on a global scale. Proven record in DEA compliance. Outstanding leader with demonstrated abilities in transforming under performing teams into high...
SUMMARY Manager with extensive experience in lean manufacturing, and Six Sigma implementation in multiple production environments. Change agent who strives to bring about breakthrough improvements in a very effective time. Adept at recognizing root cause problems solving and instituting preventive actions while developing high performing work teams. EXPERTISE * Team Leadership Manufacturing Optimization Lean & Six Sigma Str...
SUMMARY OF QUALAFICATIONS: * Twenty years of Health Care experience - Admin. & Management. Eleven years in the Biotech / Pharmaceutical Industry. * Clinical Research - (CRA, CRC, Consultant) - FDA Compliance/Quality, Systems/cGMP, GLP, GCP
Accomplishments * Improved profitability and secured a $300K savings by reducing production costs and monitoring marketing expenses through working with account management team and varied other partnerships, facilitated the onboarding of a new major Philadelphia Health System account and assisted in subsequent strategic planning and implementation * Onboarded a new pharma client while growing and maintaining position in "to...
Tags for this Online Resume: Social Media, Management, Networking, Client Communications, Communications, Content Management, Marketing Management, Sales, Sales Executive, Account Management, Customer success, client engagement
Summary A multi-faceted team player with expertise in Quality, Production and Team Development. Knowledgeable in GMP's, HAACP, Food Safety and FDA compliance. Certified ISO Auditor. Experienced with Lean Manufacturing. Experienced in process auditing and SPC. Background includes manufacturing containers used for Food, Dairy, Liquor and HABA.
Summary of Qualifications * Over 23 years of progressive management experience with a proven track record of delivering results in highly matrixed organizations * Broad foundation of applicable business skills obtained from experience in working with Operations, Sales, HR and Finance that has developed multiple leadership competencies including: Team player, Results Orientation, Innovation/Risk Taker, and Managerial Courage...
Highlights of Qualifications Multiple years of experience in community outreach engaged in environmental conservation project management and implementation. High level of performance in ability to work both collaboratively and independently with strong interpersonal skills extremely detailed orientated extensive problem solving management of data entry excellent communication skills and ability to interpret complex informat...
Tags for this Online Resume: Cardiopulmonary resuscitation (CPR), Communication Skills, Data Entry, Dec, Distribution, English Language, Excellent Communication Skills, Management, Mergers, Problem Solving
Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits
Engineering project manager with 25 years' experience designing and manufacturing medical devices and 6 years' experience in business ownership and sales. Driver of all aspects of projects from gathering customer requirements to production release. Specialist with Class II and III combination products. FDA-recognized expert with Design Controls. Highly skilled people and situation manager. Leader at coordinating all depart...
Tags for this Online Resume: Microsoft Windows, Design Controls Expert, Engineering Project Manager, CAPA Investigator, Technical Sales, ISO 13485, ISO 14971, Internal and Vendor Auditor, FMEA, 510(k), Patents
Summary: Ralph Simmons has over 30 years of experience as an attorney for industry and for the Food and Drug Administration (FDA) with respect to the FDA and international regulatory compliance of food, food ingredients, food packaging (and other food-contact substances, such as components of food processing equipment), dietary supplements, drugs, and medical devices. Mr. Simmons is an internationally-recognized expert on F...