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Online Resumes with "CAPA"
To contribute to a growing organization that will utilize my "can-do" attitude, energy, and entrepreneurial & quality engineering experience.
I have worked consistently in QC for many years. As a result of my extensive background, my roles have increasingly crossed over into Quality Assurance and Regulatory Affairs. I want to advance into the realm of Compliance and Regulations.I feel I could be a valuable asset to any company that is regulated by GMP practices.
To guide as a Compliance SME regarding federal regulations in the pharmaceutical industry.
Senior Scientist - M.S. Biologist, medical diagnostic industry, 20+ years experience. R&D, Manufacturing, Quality Assurance, Technical Support, and Quality Systems.
M.S. Biologist, molecular biology background, medical diagnostic industry. Experienced in R&D, Manufacturing, Quality Assurance, Technical Support, 21 CFR 820, audits, submissions and FDA communications. Proficient in technical reports, documentation, presentations, analytical instrumentation (HPLC, CE, UV-VIS), statistics (JMP, DOE, SPC, specifications), immunoassay development (ELISA, purification, conjugation), test meth...
Tags for this Online Resume: Medical Device, Quality, Auditing, molecular biology, manufacturing, regulatory, Quality/Regulatory, Biologics Manufacturing, MicroBiology/Environmental Monitorrig, Regulatory Affairs
Over 18 years of top performance in optimizing operations for up to 60K+ SF R&D facilities. A peak performer in establishing operational excellence in all facets of pre-clinical studies, encompassing best practices for quality, safety, compliance, and cost control. Adept at managing quality assurance for studies supporting pharmaceutical/biotech regulatory submissions by conducting independent audits, issuing audit reports...
lead project deliverables, participate in the qualification processes. Failure Mode Effect Analysis (FMEA) and Design in support of test development, and results analysis Facilitate change, Align test objectives against Traceability Matrix, articulate Software Development Life Cycle (SDLC). Independently investigate continuous or erratic problems, analyze product returns isolate and determine root cause, corrective act...
Tags for this Online Resume: Software Quality Assurance, Testing software, Designing tests, Failure Analysis, Quality Life Cycle testing, interfacing with development teams, software testing, Agile, SDLC, Testing software, SDLC, Failure Analysis, FMEA, Java, SQL-Server Script writing, Agile, development teams, Quality Lead, Tests, Corrective Action, Project Lead Engineer
I am currently looking to work in a quality role possibley in a supervisory type of position. Clinical Reasearch is another area that I am interested in.
To obtain a entry level career with in the quality assurance sector of pharmaceuticals.
Proven track record in coordinating and participating in root cause / corrective / preventive action activities CAPA, and driving defect levels down. Proven track record in and enjoy understanding the Customer’s needs / concerns and bringing the Customer focus to the appropriate internal folks and suppliers. Experience working with suppliers, with teams developing and releasing new products to Manufacturing, and with Quali...
To contribute to improving business success
Ideal Companies: Pharmaceutical drug product manufacturing/consumer products manufacturing/API
Representing a pharmaceutical or medical device company to domestic and foreign regulatory agencies.
Director or executive level responsibility.