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Associate Compliance Analyst

4 months 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 degreePrior 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 PracticesAbility to work in a team environment and independently as requiredMust have strong attention to detail and the ability to maintain focusMust be diligent, organized, and dependableProficient in oral & written communication skillsNeed 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 requiredAbility to sit for long periods of time

Equal Opportunity Employer Minorities/Women/Veterans/Disabled