Certified medical laboratory technologist with extensive experience in pharmaceutical clinical trials, clinical laboratory regulatory compliance, quality assurance, and laboratory management. Experience with most clinical laboratory testing disciplines. Expert instrument troubleshooter and workflow problem solver. Willing to take on challenging situations; attentive to detail; leader, collaborator, or independent worker;...
To obtain a position where my education and experience and previous work history would help the firm. I am knowledgeable and have worked with 21 CFR 11, 210 and 211.I was responsible for all 3rd party audits; was the responsible head for all FDA audits and responses; headed the CAPA and OOS Investigations and was involved with International Regulatory submissions as well as all FDA submissions. I was resopnsible for all OO...
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Quality Assurance, Quality Control, Manufacturing, Teaching, Bio-Statistics, Regulatory
Very driven, goal oriented, leader, multi-tasking assistant to high level executives. Resourceful, unconventional, effective, and ethical.
Ideal Companies: Legal, tropicana, Pepsi
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Executive Assistant, Entry-level manager, Office Manager, HR Assistant, Legal Assistant
My objective is to use my extensive knowledge of clinical research, FDA, ICH, and GCP guidelines to obtain a career in the Pharmaceutical/Biotech industry.
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Clinical Reserach, IRB, Human Subject Protection, Audit, Monitor
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Regulatory Affairs, Audit, Medical Device, FDA, Project Management, Quality System
· Responsible to insure good housekeeping and maintained equipment and rooms in a clean and orderly manner in accordance with cGMP and FDA requirements.
· Accurately document as required during all batch manufacturing process paying strict attention to processing step details and good documentation practice.
· Responsible for employee performance evaluation.
· Maintain the high standard of product quality.
· Coordinate ...
I want to work in Compliance for the food's industry. I want to enhance my knowledge and skills.
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Regulatory Compliance for Foods, Interspec, Product Visition, Word, FDA Food Regulations, Excel
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Project Management, Monitor, GCP-ICH, FDA, Clinical Research, Patient Safety, 21 CFR 11, Data Management, Budget and Forecast Planning
24 years in Pharmaceuticals as a scientist/chemist.
Ideal Companies: Dupont, Invitrogen
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laboratory supervisor, Chemist, Cleaning Validation, Validation, Protocol, Risk management
Promotional Material Manager with solid experience in the pharmaceutical industry. Successful working with brand managers, brand teams, medical, legal, drug regulatory departments to finalize a high volume of promotional materials and FDA submissions for RX products. Knowledge of FDA guidelines and regulations. Able to work effectively with all levels of management under tight deadlines.
