SEARCH

QA Data Reviewer Resume Example

Resume Score: 70%

Love this resume?Build Your Own Now
QA DATA REVIEWER
Professional Summary
QA Analytical Data Reviewer with experience in quality control and quality assurance.
Skills
  • Extensive HPLC and Chromatography experience, including 10 years with Empower software
  • High quality review/auditing skills
  • Data integrity audits and related investigations
  • Strong GMP background
Work History
QA Data ReviewerCompany Name - City, State04/2017 - Current
  • Review of analytical data for accuracy, completeness, and FDA compliance. Data includes lab notebooks, logbooks, chromatography, and electronic data/audit trails.
  • Performs training for documentation, GMP compliance, and various SOP's.
  • Lead Investigator on data integrity breaches in the laboratory.
  • Utilizes on-site consultants, including former FDA inspectors, to achieve a better understanding of compliance expectations.
  • Mentors less experienced analysts on documentation, integration, compliance, and expectations of the FDA.
  • Conducts monthly GMP laboratory inspections, including instrument and column logbooks.
  • Systems Administrator of instruments in the laboratory, scheduled to assist in the upcoming HPLC software transition to Empower.
Analytical Chemist IICompany Name - City, State01/2007 - 04/2017
  • Conducted testing of release, stability, in-process, cleaning verification, and validation samples according to the assigned specifications, methods and protocols.
  • Operated analytical instruments such as HPLC, FTIR, UV-Vis, Karl Fisher volumetric and coulometric moisture testing.
  • Utilized HPLC Empower software to analyze and interpret chromatography results of assay, dissolution, and related substances testing.
  • Conducted GMP peer reviews of laboratory notebooks and chromatography including on-line review of electronic data.
  • Emphasis on electronic data integrity of HPLC results, including complete and specific explanations of all method changes and updates.
  • Interfaced with peers in other departments and senior management to offer suggestions and solutions for improving efficiency, teamwork, and a better understanding of client products and their benefits.
  • Assisted in reviewing various SOP's for periodic updates.
  • Close working relationship with client through challenging projects, analyzed unusual chromatography and proposed solutions.
  • Mentored newer analysts on lab notebook documentation and corrections in accordance with QA preferences and compliance.
  • Capable of self-scheduling work assignments.
Raw Materials AnalystCompany Name - City, State09/2005 - 12/2006
  • Tested and analyzed all incoming raw materials for compliance.
Quality Assurance AuditorCompany Name - City, State06/2000 - 02/2003
  • Conducted auditing of Quality Control documents for compliance with GMP and company SOP regulations.
  • Laboratory documentation audits included raw materials, in-process, finished product, and stability testing.
Analytical Chemist IICompany Name - City, State02/2003 - 06/2005
  • Conducted testing of release, stability, and in-process samples according to the assigned specifications, methods and protocols. Testing included assay determination, dissolution, and moisture.
Education
Bachelor of Science: ChemistryUniversity of South Florida - City, State2000
Build Your Own Now

DISCLAIMER

Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

Resume Overview

School Attended

  • University of South Florida

Job Titles Held:

  • QA Data Reviewer
  • Analytical Chemist II
  • Raw Materials Analyst
  • Quality Assurance Auditor

Degrees

  • Bachelor of Science : Chemistry

Similar Resumes

View All
Data-warehouse/ETL-QA-Analyst-resume-sample

Data warehouse/ETL QA Analyst

Orrville, Ohio