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