Associate Compliance Analyst

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

• 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

• 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