**Overview** 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. **Responsibilities** + Author, track monitor, facilitate closure, and QA review of investigations, out of specification (OOS) and out of trend (OOT) reports for compliance to FDA regulations and other guides/guidelines.  + Using root cause determination techniques, perform Non-Conformance, Deviation, OOS, and OOT investigations to determine the root cause and effective corrective / preventive action (CAPA) implementation to prevent recurrence of the event.  + Interact with clients in the performance of investigation duties.  + Experience performing, reviewing and issues associated with biological laboratory testing (i.e. ELISA, PCR, Virus testing, etc).  + Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines.  + Provide cGMP guidance to functional groups such that all non-conformances are closed within defined timeframes and product release dates.  + Work with cross-functional teams to develop and track CAPA plans.  + Work with Testing operations personnel in performance of effective investigations.  + Evaluate trends of investigations and CAPA’s to identify major areas of opportunity for improvement.  + Assist during regulatory inspections or other audits as required  + Provide training to functional areas on compliance issues + Completes all requisite training (i.e. Bloodborne Pathogen, Quality Assurance, safety, etc.) + May be required to work Holidays, weekends, Overtime and/or outside of normal business hours. + Contributes to the overall operations and to the achievement of departmental goals + Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures. + Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices + May be required to assist in other departments + Other duties as assigned **Qualifications** + 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 AppTecprovides 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. **Need help finding the right job?** We can recommend jobs specifically for you! An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disabilityAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability (https://careers-wuxiapptec.icims.com/connect?back=intro&findajob=1&in\_iframe=1&hashed=-435740542) **Job Locations** _US-PA-Philadelphia_ **Job ID** _2024-13323_