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Online Resumes with "CFR Part 11"



Sr. Quality Engineer, 20 years FDA regulations, CQA, Midwest

Sr. Quality Assurance Engineer with twenty years quality experience complying with FDA regulations. Energetic team player supporting quality within all manufacturing operations.

Tags for this Online Resume: Quality Engineer, CQA, Risk Management, Quality Systems , FDA, 21CFR Part 11

Regulatory Pharmaceutical Document Specialist and Technical Writer

Brenda is a Technical Writer and Quality Assurance Regulatory Document Specialist with over ten years of experience in the pharmaceutical industry. She has extensive experience with all types of document project work, including writing, editing, formatting. She has experience as a team member for non-conformance investigations (NCs) and Corrective Action and Preventative Actions (CAPAs). Her analytical and research skil...

Lotus Notes Domino Developer

A dynamic, logical thinking, performance driven IT professional, with 15 years of experience out of which fourteen years of Lotus Notes Development including 5 years of Business Analysis experience and one year of Lotus Notes Administration experience using Notes version 7.01 & Notes version 8.4. Possess full knowledge of Software Development process including requirements definition, prototyping, Proof of concept, design,...

Software Engineer

Tags for this Online Resume: SDLC, Agile, Scrum, Java, Project Management, Oracle, 21 CFR Part11, GCP, HIPAA, HL7, Software Architect , CTO, Healthcare, Clinical Research , Offshore Development, Open source technology, EDC, RDC

Chemist

I have 14 years of experience in pharmaceutical industries. Results oriented individual with a track record of instituting and maintaining high levels of Quality Assurance and leadership. I’m seeking additional opportunities for professional development in consulting, validation, compliance or technical areas. Strong analytical and planning skills. Six Sigma Black Belt trained. Knowledge in FDA, cGMP, GLP, 21 CFR - Part 820...

Ideal Companies: Pharmaceuticals or food industries

Tags for this Online Resume: qa, validation, lims, qc

Design/Develop/Sell/Manage/Travel

Outgoing personality with strong ability to solve changing business/industry needs with application/database development. Versatile, independent thinker with team attitude.

Ideal Companies: HP, IBM, IT SERVICES COMPANY, LOOKING TO MOVE INTO IT SALES

Tags for this Online Resume: JAVA, JSP, MySQL, SQL, SAS, Database, Programming, SQL Server, ACCESS, Microsoft Office, Web Development, Design, Development, Web, TERADATA, UNIX, PROGRAMMER, ORACLE

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

Clinical Trials Manager

Dear Hiring Manager, I am interested in exploring career opportunities with your company and have therefore enclosed my resume for your review. This position seems ideal for my experience, education, skills, and career interests. I am eager to contribute my enthusiasm and teamwork to your organization. My professional goal is to enhance my research development and senior leadership experience. I believe that I could...

Quality Assurance Manager - Clinical

Seeking position where I can maximize my quality management background in clinical trials, apply experience in SDLC and 21 CFR Part 11 and utilize my strong analytical and communication skills.

Tags for this Online Resume: Clinical Quality, SDLC, Part 11, Quality Audit

Computer System validation Specialist

An IT professional with over 10 years experience as a validation specialist, senior/lead technical writer, documentation manager, analyst, tester, and end-user trainer. IT experience is complimented by solid management and leadership experience gained as a US Army officer.

Tags for this Online Resume: validation, documentation

Senior IT Manager and Pharmaceutical Scientist--15 years Experience

A highly experienced and hands-on technical IT project manager and laboratory automation scientist with in-depth knowledge of the SDLC and pharmaceutical regulations (ie. 21 CFR part 11, and GLP regulations). 15 years of experience.

Tags for this Online Resume: New Jersey, Pharmaceutical, Automation, Technical Lead, Laboratory

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