Associate Compliance Analyst

WuXi AppTec • Marietta, Georgia, United States • 4d ago

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.

Tuesday to Saturday 8 AM to 5 PM

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