QA Specialist
hace 7 meses
**Quality Specialist**
**Work Location: Colombia**
**About RWS**:
RWS Holdings plc is the world’s leading provider of technology-enabled language, content management and intellectual property services. We help our customers to connect with and bring new ideas to people globally by communicating business critical content at scale and enabling the protection and realization of their innovations.
Our vision is to help organizations interact effectively with people anywhere in the world by solving their language, content and market access challenges through our collective global intelligence, deep expertise and smart technology.
Customers include 90 of the globe’s top 100 brands, the top 10 pharmaceutical companies and 18 of the top 20 patent filers worldwide. Our client base spans Europe, Asia Pacific, and North and South America across the technology, pharmaceutical, medical, legal, chemical, automotive, government and telecommunications sectors, which we serve from offices across five continents.
Founded in 1958, RWS is headquartered in the UK and publicly listed on AIM, the London Stock Exchange regulated market (RWS.L).
RWS Regulated Industries division: provides a full suite of language services exclusively for highly regulated industries such as Life Sciences, Healthcare, Financial services, and Legal industries. This includes language solutions for clinical trial management and linguistic validation of Clinical Outcomes Assessments (COAs), insurance, retail, commercial and investment banking, compliance, mergers & acquisitions, and Litigation.
**About The Role**:
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.
**Responsibilities**:
- 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
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