SQAFYI - Software QA Resource - FYI

US-NJ-Fairfield: Quality Assurance

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Date: 01-Aug-2011

Quality Assurance / Document Auditor

Responsible for performing data documentation review for release of test Certificates of Analysis. Release Certificates of Analysis in LIMS Assist Quality Assurance Manager with specific activities. Specific responsibilities Review completed job files for accuracy of information, completeness, cGMP data documentation compliance and correctness. Review data entry into LIMS, Return to analyst for corrections as needed Review necessary corrections with analysts as needed. Generate Certificates of Analysis with electronic signature Perform audits of laboratory log books. Review corrective actions & training issues with QA Manager. Review incoming USP supplements and other compendial publications for changes relevant to the laboratory. Assist QA Manager as needed At least 2 -3 years prior QA experience or related laboratory experience. Bachelor's Degree in Science (Chemistry / Biology) Knowledge of basic laboratory principles. Understand cGMP practices and company standard operating procedures (SOPs) for working in the laboratory.

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Thank you,
Team SQAFYI - Software QA Resource FYI

US-NJ-Fairfield: Quality Assurance