Fda resumes in Charlotte, NC

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Manufacturing Process

Fort Mill, SC
... Working knowledge and practical experience with cGMP and FDA regulations in a chemistry laboratory environment. Familiar with quality systems [i.e. Laboratory Investigation Reports (LIR), Corrective and Preventive Actions (CAPA), calibration, ... - Mar 10

Manager Quality

Charlotte, NC
... * Performed technical and GMP gap assessment of quality system against ISO 13485 standards and FDA 21 CFR Part 820 requirements and developed/ revised/ enhanced procedures in preparation for pending ISO audit and planned product transfer to a ... - 2017 Dec 13

Manager Project

Charlotte, NC
... CMMI course certificate FDA Quality Assurance Seminars and certifications AAMI Verification and Validation Seminars and certifications Quality Assurance Institute – C.S.T.E. Certified Software Test Engineer Continua Health Alliance (medical device ... - 2017 Nov 06

Environmental Health Safety and Compliance

Rock Hill, SC
... and seminars Serve as a liaison between DHEC and the community Responsible for reading and re-reading Regulations 61-25 and FDA Food Code Taken at least 20 FDA ORA-U online classes (Required 5-10 per year) Winn Dixie Rock Hill, SC Customer Service ... - 2017 Oct 08

Medical Assistant

Charlotte, NC
... FDA Responses-Complete response letters, problems encountered during drug manufacture, safety, efficacy, bioequivalence, stability, quality of final product, labeling. Research experience Duke University medical research scientist, carrying out ... - 2017 Oct 05

Engineer Project Manager Quality Process

Charlotte, NC
... Reviewed current GMP and FDA regulations and guidelines for pharmaceutical industry. Monitored environmental conditions (temperature, pressure, humidity, and particulate concentration) in clean room areas of facility. Review batch records for ... - 2017 Oct 02

Skilled to work with frozen, paraffin, and plastic embedded tissue.

Charlotte, NC
... to the Bioresearch Monitoring Program The Clinical Investigator: Responsibilities in Medical Device Trial Preparation for an FDA Sponsor Inspection Preparation for an FDA Clinical Investigator Inspection Preparation for an FDA Institutional Review ... - 2017 Sep 05

Customer Service Engineering

Gastonia, NC
... Dispense and removal of hazardous materials per safety and FDA protocols. Certified and trained 12 new employees at 5 stations for the new production line in Ireland. Superior Automotive, Morgan Hill, Ca 2011-2013 Office Manager and Bookkeeper. ... - 2017 Aug 21

Engineer Professional Experience

Charlotte, NC
... Controls, Risk Management, CAPA, Post-market Surveillance, Writing Validation Protocols- IQ/OQ/PQ/ SOP’s, Process Validation, Master Validation Plans, Pro-E, Remediation, PFMEA, 21 CFR Part 820 - Quality System Regulation (QSR), FDA and Gage R&R. ... - 2017 Aug 14

Sales Manager

Matthews, NC
... FDA 510(K); ISO; Declaration of Conformity to move products in and out of the country and satisfy regulatory mandates. Committee Chair: Collaborated with Graphics Department (Private Label) to establish timelines and guidelines for customer ... - 2017 Aug 08
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