Associate Compliance Analyst

3 weeks ago

Marietta, United States WuXi AppTec Full time

Overview

WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Quality Department for an Associate Compliance Analyst.

Shift is Tuesday - Saturday

Responsibilities

* Review laboratory worksheets and electronic records
* Review, sign, and send final reports to clients
* Interact with clients regarding final report status and report amendments
* Contributes to the overall operations and to the achievement of departmental goals
* Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required
* Works under supervision from supervisor or senior personnel
* Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures
* May be required to work holidays and weekends
* May be required to work overtime
* May be required to assist in other departments
* Other duties as assigned

Qualifications

* Experience / Education
* Associates or Bachelor's Degree or equivalent experience
* 2 years comparable experience in a regulated industry or 4 years without degree
* Prior QA/QC experience in electronic record review (i.e. - LIMS, batch records) preferred

Knowledge / Skills / Abilities:

* Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
* Ability to work in a team environment and independently as required
* Must have strong attention to detail and the ability to maintain focus
* Must be diligent, organized, and dependable
* Proficient in oral & written communication skills
* Need to be able to read, write and understand English
* Proficient in computer programs ( e.g., Microsoft Office)

Physical Requirements:

* Must be able to work in an office environment with minimal noise conditions
* Must be able to wear appropriate PPE when required
* Ability to sit for long periods of time



Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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