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Online Resumes with "CAPA "



Senior Quality Engineer - 16yrs experience in Process, Product & Systems Quality

To contribute to a growing organization that will utilize my "can-do" attitude, energy, and entrepreneurial & quality engineering experience.

Tags for this Online Resume: Six Sigma Greenbelt, ISO 9000 & 14000, CQE & CQA, RAB Lead Auditor, Quality Management Systems, CAPA

Quality Control Laboratory Experience in Diagnostic, Pharmaceutical and Medical Devices Labs

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.

Tags for this Online Resume: CAPA, Quality Control, Documentation, Quality Assurance, Regulatory Affairs, Technical Writing

Compliance Senior Consultant

To guide as a Compliance SME regarding federal regulations in the pharmaceutical industry.

Tags for this Online Resume: CSV, Compliance, Technical Writer, CAPA, Investigations

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

OPERATIONS / QUALITY ASSURANCE / SAFETY MANAGEMENT

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...

Tags for this Online Resume: Operations Manager, Animal Research, GLP, Safety, Validation, FDA

Quality Engineering, Boston, MA

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

Quality Assurance, Chicago

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.

Tags for this Online Resume: life science, safety, research, quality assurance, medical technologist, CAPA

Agricultural Technician

To obtain a entry level career with in the quality assurance sector of pharmaceuticals.

Tags for this Online Resume: CAPA, Excel, FDA, Details, ISO, Pharmaceuticals

Quality Engineer

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...

Featured Profile

Regulatory Affairs, Analytical Development R & D, Quality and Compliance

To contribute to improving business success

Ideal Companies: Pharmaceutical drug product manufacturing/consumer products manufacturing/API

Tags for this Online Resume: Leadership, Regulatory Affairs, Quality, Compliance, Analytical Development, Research and Development

Quality Scientist presented before FDA

Representing a pharmaceutical or medical device company to domestic and foreign regulatory agencies.

Tags for this Online Resume: Quality Control, Stability Coordinator, HPLC Lab Scientist, Quality Assurance, CAPA Coordinator, Investigator

Quality Manager-ASQ Certified-Tucson, AZ

Director or executive level responsibility.

Tags for this Online Resume: Lean, ISO, Leadership, SPC, PPM, CAPA