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Title

QA Associate III 

EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
 
Full-Time/Part-Time Full-Time  
Description

Responsible for executing and supporting QA operation functions including assess, evaluate, and review operations on the floor against cGMPs to assure real time observation of activities, issue identification/ resolution including proper and timely documentation. Perform QA inspections of finished goods and other materials. Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be proactively shared across QA and the business.   Identifies, classifies and reports deviations, as appropriate. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations. Provides guidance directives regarding remediation activities required to continue production.   Oversees execution of remediation/CAPA activities required to continue production or move a process along.   Performs independent technical review of documentation including Batch Production Records during and post-execution of cGMP activities as well as logging and filing of documentation.  Ensures all specifications are met and that requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved and approved and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.

 
Location Gainesville, GA  

This position is currently not accepting applications.

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