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Online Resumes with "FDA 21 CFR"



Position as a Senior Information Technology professional using my experience in personnel and project management leading IT services for the development and production of software products.

Senior level experience in product lifecycle: personnel management (client & team), project planning, budgeting, requirements and analysis, design, risk management, coding / manufacturing, quality assurance, systems integration, validation & verification, release, support, maintenance, and auditing.

Ideal Companies: Sun Microsystems, McKesson, IBM

Tags for this Online Resume: Director, Manager

Procurement Specialist - 10 years experience - Purchasing and Supply-Chain Management

To further my career in Supply-Chain Mgmt and Purchasing by offering 7 years of process improvements and cost saving strategies. I earned a Bachelors degree in Business Management with woking knowledge of FDA 21CFR820, ISO 13485, and ISO 9001.

QA Manager, document Control

I have over 30 years of experience in the medical device, pharmaceutical, and biologics experience with a strong background in Class III Medical Device Safety and pharmaceutical quality and compliance. My management background included coordinating inspection assignments, managing investigation activities and assigning investigation tasks to all involved departments, preparing summary reports, reporting metrics for complain...

Quality Assurance Associate Managert

Quality Assurance professional with problem-solving abilities in Pharmaceutical and Biotechnology industries. Primary strengths include US (FDA) 21 CFR, and ICH Q7A Guidance for API Manufacture, Quality Systems development and implementation and strong auditing skills. Introduced and managed electronic document management software including validation, implementation, and maintenance, as well as project team leadership. R...

Tags for this Online Resume: Quality Assurance, FDA regulations, CAPA, Document Control, Change control

Senior Scientist - six years; Associate Scientist II - three years; Bioprocess associate -threr years; Research associate for 5 years; Instructor (HS) - for five years

Experienced senior scientist with expertise in protein or antibody purification. Followed cGMP training with FDA 21CFR part 11 and demonstrated abilities in the scale-up and transfer of purification processes from the laboratory to production. The goal will be using my experience and knowledges for contributions to the biotech industry.

Tags for this Online Resume: Process Development for purification, Monoclonal Antibody purification, GMP Compliance, Large scale design for purification, techniques transfer and disposable technology , team management

Senior staff scientist / Program Manager

Manage / implement a product stability program under current regulations; manage implementation of FDA requirements post 510(k) clearance

Ideal Companies: medical device companies; adjunct college professor; education manager within a company

Tags for this Online Resume: Product Quality Support, Product stability , medical device software validation, adjunct professor_biology

Quality Assurance Manager

As an expert quality management strategist working in the Automotive and Medical Devices industry and in the following standards and concepts as: ISO 9000, TS 16949, ISO 22000, ISO14001, GMP, FDA 21 CFR 820, JPal, Lean Manufacturing, Six Sigma, Etc… for over almost two decades, I offer my keen business acumen and superior quality management skills attached on my resume to your company with an inclination to meet quality sta...

Tags for this Online Resume: Reynosa, Quality Manager, Quality, Matamoros, Queretaro, Medical Devices

Quality Manager

I am a quality/lean professional who has worked in highly regulated environment and know what it takes to have manufacturing and office process compliant to regulations with minimum impact to productivity.

Tags for this Online Resume: ISO 9001:2008, Electro-Mechanical Integration, MINITAB, ISO 13485:2003 , FDA 21CFR820 , Lean Manufacturing

Engineer - 20 Years of Experience - Near 94565

Henry Martinez has twenty-six years’ experience in the areas of Advanced Control Systems, Instrumentation Specialist, Quality Assurance, Design and Diagnostic set-up for R&D experimentation. During that time he worked on High Profile Projects under the SDI (Strategic Defense Initiative) and the Brilliant Pebbles Programs supported and funded by DARPA (Defense Advanced Research Projects Agency). During the past 15 years, he ...

Tags for this Online Resume: Validation Engineer, Packaging Engineer, Controls Engineer, BMS, Compliance, FDA

Quality Manager - 15 Years of Experience - Near 55044

Tags for this Online Resume: Six Sigma Black Belt, Lean Manufacturing, Continuous Improvement, AS9100 and AS9102, FDA 21 CFR Part 820

Quality & compliance professional with 24 yrs of experience

With over 24 years of hands on experience in positions of increasing responsibility in Pharmaceutical, Bio and Medical Devices companies. Areas of expertise includes: Quality and compliance (FDA /21 CFR ,809/ICH, GxP’s), CSV (Part 11 and GAMP5) and Serialization (DSCSA), Technical Support (SME for manufacturing and quality areas), Audit in manufacturing and lab areas. Other Quality areas: revision/approval of SOP and Qualif...

Tags for this Online Resume: Quality, Compliance , Validation, Qualification, 21 CFR Part 11, Change control, CSV, 21 CFR 210,211, 809

Featured Profile

Senior Process Validation Lead

Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.