Job Location : New York,NY, USA
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Client Escalation Report Expert
Who We Are:
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.
What You Will Be Doing:
The Client Escalation Report (CER) 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 CER Expert is a specialist in all formal client-facing reports related to non-conformances documented in Compliance Report (CRs).
Report Management:
* Initial intake to determine if a formal report is in fact warranted and appropriate based on the
* severity of the error and its impact
* Create a schedule for CR investigation, approvals, drafting, delivery, as needed
* Write the CER itself based on the CR findings
* Host and lead a CER call with all relevant parties to ensure everyone agrees in the content
* Handle any responses to client feedback on CER and deliver an updated CER version if needed
* Occasionally attend client calls in the event that the client's QA team deems a call is required
* Perform and oversee Effectiveness Checks of the actions upon scheduled timeframes as needed
Process Development:
* Manage CER Request Form improvements
* Maintain related controlled documents (e.g. SOPs, WIs)
* Track CER data to identify trends
* Decrease the overall volume of CER reports being requested by creating barriers to entry for
* CER requests and educating client-facing POCs on how to solve issues without
* offering/promising a formal report to clients (e.g. email, meetings, calls, QBRs, etc.)
* By applying I confirm I have read and accept TransPerfect's Privacy Policy:
* Add value to the overall process by driving novel improvement concepts (e.g. the creation of a CER
* or action plan repository, etc.)
Who We Are Looking For:
Your experience includes:
* Minimum Bachelor's degree or its equivalent
* Client facing and/or complaint handling experience
* Experience in root cause analysis
* Multitasking in a fast paced environment
* Some experience with handling process changes and managing solution-based improvement initiatives
* Excellent writing skills and knowledge of appropriate client language
* Excellent organization skills and the ability to self-monitor and efficiently handle and prioritize tasks
A plus would be:
* Experience in quality assurance, CAPAs and compliance
* Experience as QA in regulated industries (such as Finance, Healthcare, Pharmaceutical, CRO,
* Medical Device, Investigative Site, etc.)
About Us:
Where Your Career Is Going:
At TransPerfect, there are a lot of growth opportunities. All departments offer career growth and development that can combine your skills, interest and experience. We encourage our employees to have a continuous dialogue with management about growth opportunities throughout your tenure with the company.
Why TransPerfect:
For more than 25 years, we have honed a culture where all kinds of ideas are shared and new ventures are not only welcomed, but also encouraged. In this fast-paced environment, employees are intellectually stimulated so they can grow alongside the organization. From Intern to President, we believe that every single employee should have a voice and contribute to the amazing services we offer our clients.
We also offer a comprehensive benefits package including medical, dental, and vision insurance, 401k matching, membership to child-care providers, and other TransPerks. You even get your birthday off because let's face it, we're stoked that you were born.
TransPerfect 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
For more information on the TransPerfect Family of Companies, please visit our website at www.transperfect.com.