Posted on 09/11/2017

Quality Auditor

WuXi AppTec - Marietta, GA

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Job Description

Temporary position (2 - 3 months) to review systems and processes to prepare for FDA inspections

 

 

 

 

 

 

 

+ Review laboratory testing to ensure GMP procedures are followed (e.g, Good Documentation practices, laboratory cleaning practices)

 

 

 

+ Ensure laboratory investigations and deviations are issued as required

 

 

 

+ General laboratory walk-through inspections

 

 

 

+ Be able to communicate findings in an understandable audit report

 

 

 

+ Assist with audit follow to ensure implementation and effectiveness of corrective actions

 

 

 

 

 

 

 

 

 

+ Auditing experience in GMP environment – 2 to 3 years on auditing team required

 

 

 

+ Experience with electronic document systems a plus, e.g., LIMS in a laboratory, MasterControl or similar system

 

 

 

+ Data entry in Excel and/or MasterControl

 

 

 

+ Microsoft Office skills required (intermediate)

 

 

 

+ Proficient in Oral & Written communication skills

 

 

 

+ Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices

 

 

 

+ Need to be able to read, write and understand English

 

 

 

+ Must be able to work in lab setting with exposure to biohazards / chemicals

 

 

 

+ Must be able to wear appropriate PPE as needed

 

 

 

+ Must be able to work in lab environment with variable noise levels

 

 

 

+ Ability to stand / sit / walk for long periods of time

 

 

 

 

 

 

 

 

 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

 

 

 

 

 

Job ID: 2017-3182

 

External Company Name: WuXi AppTec Inc

 

External Company URL: wuxiapptec.com

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