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Online Resumes with "Analytical Laboratory Management"
I have a hands-on experience interacting with suppliers, internal customers, and subject matter experts to ensure thorough evaluation and accuracy of discrepancies and investigations, identifying root cause, coordinating corrective and preventive action plans, writing summaries, and reviewing reference documents. I am experienced in change control process for externally initiated material changes in accordance with cGMP, U...
Laboratory and manufacturing manager with ISO 9001, 17025, cGxP, C.I. and method/process validation experience
To find a position utilizing some or all of the following competencies: • Food, drug, medical device, and consumer goods manufacturing experience. • Skilled QC analytical/R&D laboratory manager w/10 direct reports. • ISO 9001/17025 compliance experience in manufacturing environment. • Laboratory quality system development and cGMP writing and auditing. • Continuous Improvement and metrics monitoring experience. • Deve...
I am an Analytical Laboratory Manager with over 5 years experience managing and developing laboratory teams. Expertise in training, motivating and using my extensive knowledge of cGMP to develop an effective, efficient and continually audit ready laboratory. Additionally, my many years experience as an Analytical Chemist give me the incite into the way people think so that I can relate to any type of situation that arises. ...
QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.
Ideal Companies: small start-up company
Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)