Localization Academy

LV QA Specialist

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Under the direct supervision of a Quality Manager, the Quality Specialist assists in overseeing development, implementation, and continual improvement of quality systems, programs, and processes. This position assists in the implementation of the policies and objectives for quality and the underlying organizational processes, ensuring compliance to various standards, improvement of processes, development, and monitoring of appropriate key performance indicators. Additionally, the Quality Specialist supports internal and external audits, and assists in review, resolution and closure of corrective actions, client feedback and internal nonconformities.

 

The Quality Specialist is also responsible for all aspects of supplier compliance and quality including the monitoring of and reporting of supplier performance, and the issuing and resolution of supplier CAPAs. The role will provide timely feedback to suppliers regarding their performance and assist in making determinations related to vendor approval status. The Quality Specialist will assist in developing and implementing approved process changes related to Vendor Relations and may complete special projects.

 

About Regulated Industries

 

RWS Regulated Industries is a highly specialized division of RWS, a world-leading provider of technology-enabled language, content, and intellectual property services. The Regulated Industries division is focused on developing translation and content management solutions tailored to address the complex regulatory environment in force with premium sectors such as Life Sciences and Healthcare (pharmaceuticals, medical devices, CROs, healthcare companies), Finance (banks, asset management companies, insurance providers, fintech) and Legal (law firms, audit companies).  

 

  • Maintain understanding of company-wide project planning, project management, and technical services procedures, and knowledge of all other Company processes.
  • Assist in the design and implementation of internal systems and documented improvement projects to address them.
  • Assist in the preparation of global ISO Quality Management System documents, maintenance, revisions, and version control.
  • Work with department members and divisional personnel to ensure all Quality Management documents are up-to-date and reviewed periodically.
  • Assist in the completion of incoming quality questionnaires for various customer compliance departments.
  • Monitor client feedback and customer satisfaction survey results to identify areas for continual improvement.
  • Manage the supplier feedback process and review, monitor, and analyze performance data for each supplier to determine when corrective action or additional training may be required.
  • Generate reports on supplier performance, reviewing data, analyzing trends, and making determinations regarding the need to launch supplier quality investigations and vendor CAPAs
  • Provide feedback to suppliers regarding their performance and collaborate with suppliers to create quality improvement or training plans.
  • Administer supplier CAPAs, providing input, oversight and approval to investigation and root cause analysis, identification, and approval of CAPA Plans, confirmation of CAPA implementation and Effectiveness through review of objective evidence.
  • Monitor and assist in facilitating open Corrective Action Plans for timely completion.
  • Assist in the preparation of Management Review presentations while contributing to the reporting of customer and internal KPIs.
  • Participate and assist in the review, root cause, and resolution of customer feedback.
  • Assist in facilitating audits conducted by both internal and external parties.
  • Maintain up-to-date knowledge of industry trends in life sciences translation, regulatory changes that may impact delivery of translation services as well as the competitive landscape within the localization for life sciences space.
  • Actively participates in team and other meetings. Assist in implementing reporting procedures for timely and accurate reporting requirements.
  • Suggest actions for the purpose of improving efficiency and product quality and providing direction for meeting the company’s quality objectives.
  • Assist in developing training material related to QMS controlled documentation.
  • Assist in developing and supporting department/team goals and objectives.

Additional Duties

  • Performs other related duties, as assigned, for the purpose of ensuring the efficient and effective completion and shipment of projects.

Note: The above description is illustrative of tasks and responsibilities. It is not meant to be all inclusive of every task or responsibility.  Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.