Corrective and Preventive Action Expert

1 week ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. The CAPA Expert impacts all aspects of TransPerfect’s Global Quality Management System (QMS), which is compliant to all applicable international and local statutory and regulatory requirements (e.g., 21 CFR Part 11 and GCP/ICH) as well as international standards such as ISO 9001 and ISO 17100. The CAPA Expert is a specialist in all formal client-facing reports related to non-conformances documented in Compliance Reports (CRs). They drive the CAPA process from start to finish with the goals of minimal impact to operations, consistency in client reporting, shorter report turnaround times, and a decrease in overall CAPA volume. The CAPA Expert is responsible for owning, driving and overseeing CAPAs from the time of request to client delivery and managing any post-delivery client feedback, and for driving continual improvement based on evolving needs. Description CAPA Report Management: Initial intake to determine if a CAPA Report is warranted based on the severity of error and impact Preflight of CAPA requests to survey the client relationship and type of report needed (NTF, NC, CAPA) Ensure all relevant CRs are properly documented in TransPerfect’s Quality Management System (QMS) Create an internal schedule for CR investigation, approval, drafting, and delivery Follow up to ensure everything is on track Write the CAPA Report based on the CRs Host and lead CAPA calls with relevant parties to ensure agreement on content Ensure QA compliance and avoid audit risks Deliver to the client-facing POC Maintain internal storage of CAPA Reports and related documentation Handle responses to client feedback on CAPA Reports and deliver updated CAPA Reports as needed Attend client calls as needed to present CAPA Report Partner with client’s QA Department to ensure client satisfaction Track actions promised to clients in CAPA Reports and collect/validate objective evidence of completion Perform and oversee Effectiveness Checks to measure the success of actions on scheduled timeframes Additional Responsibilities: Supporting At-Risk Client initiatives including non-standard requests for trend analysis, Post-Mortems, Quality Improvement Plans (QIPs), Remediation Plans Routine client-facing CR reporting outside of formal CAPAs (e.g., Excel format) QA-to-QA client partnerships including routine meetings, reporting on Key Quality Indicators (KQIs), reviewing Quality Assurance Agreements (QAAs) Client QBR Meeting support Process Development: Manage CAPA Request Form improvements Regularly assess workflow to ensure efficiency Monitor initiation, tracking, and storage mechanisms Note training gaps and partner with L&D to mitigate Maintain CAPA related Bookstack reference content Track CAPA data to identify trends Decrease the overall volume of CAPA reports by driving down critical issues and educating client-facing POCs on resolving issues without offering formal reports (informal updates via email, meetings, calls, QBRs, etc.) Complete all other tasks deemed appropriate for the role and assigned by the manager/supervisor. Required Qualifications & Experience: Minimum Bachelor’s degree or its equivalent Experience in complaint handling and due diligence Fluency in English (written and verbal) Excellent writing skills and knowledge of appropriate client language Excellent organization skills and the ability to self-monitor and efficiently handle and prioritize tasks Clear communication skills including delegation of tasks A consistent positive and professional attitude and the desire to contribute to the CAPA culture Natural leadership in calls/meetings Exceptional problem solving and critical thinking Deadline oriented A desire to continually improve and the ability to take initiative independently Desired Experience: Trend/data analysis experience Experience in root cause analysis methodologies In order to apply, please submit your CV in English . Seniority level Associate Employment type Full-time Job function Quality Assurance and Writing/Editing Industries Translation and Localization Referrals increase your chances of interviewing at TransPerfect by 2x Location and compensation information: Cranbury, NJ; $125,000.00-$214,000.00 We’re not including unrelated job suggestions below in this refined description to maintain focus on this role. #J-18808-Ljbffr TransPerfect