Capa Expert

The Quality Assurance (QA) Department is an independent, neutral branch of TransPerfect. The goals of the department are simple: look out for the best interests of TransPerfect and its clients and promote and improve quality.

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 Report (CRs). They drive the CAPA process from start to finish with the goals of:

- Minimal impact to operations to pass along internal cost savings
- Consistency in reporting for clients
- Shorter report turnaround times (TATs)
- Effectiveness Checks diligence
- A decrease in the overall volume of CAPAs being requested
- 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.
- In addition to managing CAPA reports, the CAPA Expert will also own the CAPA process overall and drive continual improvement based on its evolving needs.

**Description**

**CAPA Report Management**:

- Initial intake to determine if a CAPA Report is in fact warranted and appropriate based on the severity of error and its 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(s), approval(s), drafting, delivery
- Follow up to ensure everything is on track
- Write the CAPA Report based on the CRs
- Host and lead CAPA call(s) with all relevant parties to ensure everyone agrees in the content
- Ensure QA compliance and avoid any audit risks
- Deliver to the client-facing POC
- Maintain internal storage of CAPA Reports and associated documentation
- Handle any 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 as promised to clients in CAPA Reports and collect/validate objective evidence of completion
- Perform and oversee Effectiveness Checks to measure success of the actions upon scheduled timeframes, as needed

**Additional Responsibilities**:

- Supporting At-Risk Client initiative 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
- Routine client audit support

**Process Development**:

- Manage CAPA Request Form improvements
- Regularly assess workflow to ensure efficiency
- Monitor initiation, tracking, and storage mechanisms
- Take note of training gaps and partner with L&D to mitigate
- Maintain CAPA related Bookstack reference content
- Track CAPA data to identify trends
- Complete all other tasks that are 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