Investigate and review non-conforming laboratory analytical chemistry testing results to determine root cause and product impact using root cause analysis, DSC, HPLC/UPLC; Conduct analytical chemical testing and laboratory investigations of OOS/OOT results for compliance with FDA regulations; Review and troubleshoot technical issues associated with biological laboratory testing, including ELISA, PCR, and virus testing; Provide cGMP guidance to ensure all non-conformances are closed to meet defined product release dates using Master Control, LIMS, Blue Mountain RAM; Develop and track CAPA plans for quality assurance; Evaluate trends in investigations and CAPA to identify major areas of opportunity for improvement; Implement change controls associated with laboratory equipment; Review and revise existing SOPs and test methods.

• Must have a Master’s Degree in Chemistry, Biochemistry, or Biological Science plus skills and working knowledge of Master Control, LIMS, Blue Mountain RAM, OOS/OOT, CAPA, DSC, HPLC/UPLC, ELIZA.

  Job location: Philadelphia, PA. Submit résumé referencing job code SAB008 to HR, WuXi Advanced Therapy Inc., 4751 League Island Blvd., Philadelphia, PA 19112.

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.