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Online Resumes with "fda "



Senior Research Associate in Pharmaceutical Development

The ideal job would utilize the technical skills that I have attained as a bench scientist in formulation and preformulation to move projects from preclinical into clinical development. In terms of a job at the bench, I am most interested in continuing to grow my experience in formulation (solid dosage fom) development. I am however, open to challenging myself in other roles such as technical writing, regulatory and project...

Ideal Companies: Abbott, Genentech, Astra Zeneca, Roche, Lilly, FDA,

Tags for this Online Resume: HPLC, preformulation, physical and chemical characterization, formulation, solid dosage forms, pharmaceutical development, analytical chemistry, LC-MS

Featured Profile

Operations Manager - Medical Device Manufacturing - FDA Regulated Inductry

To successfully lead an organization into higher quality, higher efficiency manufacturing.

Director QA/QC Validations - +25 years experience - Pharmaceutical FDA, DEA, cGMP

EXECUTIVE LEVEL QUALITY PROFESSIONAL with extensive expertise working in a cGMP, FDA, DEA regulated pharmaceutical environment. Validations, (developing and executing validation protocols) calibrations, SOP’s and training are my areas of expertise. Self motivated, team player, a great leader with over 25 years of experience in all aspects of quality

Tags for this Online Resume: Quality Assurance, Quality Control, FDA, Validations, Pharmaceutical, cGMP

Software Testing/QA Engineer, 6 years experience

SOFTWARE TESTING professional recognized as someone counted on to “take most challenging tasks with a 'cool and helpful presence'“ and for going out of the way to learn new technical subject areas. Known for a combination of focused analytical skills and interpersonal strengths. With six years of experience having deep background in the design, development and testing of software with expertise in manual testing while worki...

Goal focused Quality Leader in medical devices and pharmaceuticals

Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...

Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.

Tags for this Online Resume: Quality Systems Management, Regulatory Compliance, ISO 9001:2000/ISO 13485:2003, Pharmaceutical GMPs

Featured Profile

Operations / Quality Manager - 20 years experience

Manage in the Cosmetic or Food Industry as a Operations or Quality Manager.

Tags for this Online Resume: Regulatory Compliance, FDA / USDA Compliance, Develop / train SOP's, LEAN Manufacturing, MRP Proficient, Quality Improvements

Featured Profile

Medical Technologist/Regulatory Affairs Professional with 7 clinical research and laboratory science years experience and extensive knowledge of cGMP, FDA regulations, CAP/CLIA, SOP preparations and editing, clinical research project management.

Seeking a position within an esteemed organization where my expertise would add great value.

Tags for this Online Resume: Clinical Research Specialist, Clinical Laboratory Specialist, Biologist, QA/QC International Coordinator, Regulatory Affairs Professional, Drug Safety Associate

Business and Technology Leadership

My name is Mark Rosche and I solve problems, both business and technical in nature and provide thought leadership to help drive operational effectiveness throughout organizational structures.

Ideal Companies: Pharmaceuticals, Healthcare, High Technology

Tags for this Online Resume: Project Manager, Director of IT, CIO

Technical Manufacturing, Development and Marketing Professional

To apply my development, production and project management experience, combined with my business education, towards a business analysis, project management or technical marketing position.

Tags for this Online Resume: service blueprinting, FDA GMP, Project Management, petroleum, energy, Six Sigma Green Belt, MBA, manufacturing, diagnostics, Design Control