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Online Resumes with "FDA compliance "



Chemist

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

Supervisr, Reagent process

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.

Tags for this Online Resume: GMP, Non-conforming, Laboratory experience, CAPA, FDA compliance, Auditing

Department Manager - 13 Years of Experience - Near 68135

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...

Tags for this Online Resume: Manufacturing, Troubleshooting, Accounting, API, Application Program Interface, Management, Pharmaceutical, Services, Utilities, Automation, steel, "project management"

Department Manager - 20 Years of Experience - Near 45302

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...

Tags for this Online Resume: Training, Capital Equipment, Leadership, Manufacturing, Packaging, PET, Plastics

Clinical Research Associate - 11 Years of Experience - Near 94112

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

Tags for this Online Resume: Management, Compliance, Quality, Quality Assurance, Assessments, Audit, Cancer, oncology, clinical, trial, gcp, protocol, pharmaceutical

Marketing - 19 Years of Experience - Near 19382

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

Production Inspector

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.

Tags for this Online Resume: Audit, ISO, Desktop Computer, Product Development, Quality Assurance, Test, Documentation, Inventory, Quality, SPC

Supply Chain Manager

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...

Tags for this Online Resume: Appraisals, Complaints, Distribution, Employee Relations, Human Resources, Inventory, Leadership, Management, P&L, Process Improvement

Chemist

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

Featured Profile

Engineering Manager - 31 Years of Experience - Near 85224

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...

Ideal Companies: Medical Device Companies, Employees 0f 100-250

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

Featured Profile

Senior Legal Counsel

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...

Tags for this Online Resume: Litigation, Securities, Compliance, Legal, Packaging, Drafting, Management, Medical, Medical Devices, Assessments