TransPerfect
Location
São Paulo, SP | Brazil
Job description
Important information: This position, initially, would start as a freelance collaboration, involving remote work from your home address from your home address. The collaboration will be full time (40 hours per week), Monday to Friday 09:00-18:00 with one hour for your lunch. Long-term the intention is to convert the freelance collaboration into an in-house position on a permanent contract (time frame not yet determined). Overview : 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 promote and improve quality. The Quality Assurance Auditor directly impacts all aspects of TransPerfect’s Global Quality Management System, 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. They play a vital role in the maintenance, establishment and development of Quality Assurance programs, policies, processes and procedures. The Quality Assurance Auditor is responsible for ensuring customer satisfaction and retention by carrying out compliance and audit-related tasks as well as providing follow-up activity with customers, auditors, vendors or other forms of quality and process inspections. A Quality Assurance Auditor acts as a change agent that will foster a quality-driven culture, promote innovative practices that ensure quality and success, and integrate quality practices and accountability into all activities. Position responsibilities: Managing and coordinating customer audits and associated communication. Creating customer audit programs and schedules. Managing and coordinating preparation for and hosting of customer audits including internal resources for customer audits. Conducting and supporting calls with customer auditors and quality representatives. Receiving and completing audit work papers by documenting audit findings. Managing and resolving customer audit follow up assignments within required timeframes. Investigating findings or adverse experiences and operational problems to identify root cause and effective corrective and preventive actions to drive improvements with a consideration of corporate processes for alignment. Consulting project teams on resolution of audit findings. Using the existing auditing platforms to analyze findings. Bringing company strengths and weaknesses to the attention of management. This includes creating a report on those trends to management’s attention on a scheduled periodic basis and analyzing, evaluating, improving/developing, and implementing control systems that continually optimize operations or utilize technologies on a worldwide level. Reviewing effectiveness of Corrective and Preventive Action Plans (CAPA), resulted from customer audits, on a scheduled basis. Support of management review to collate and present customer audit data. Maintaining awareness of current industry trends, technology, and developments. Handling additional duties and special projects to ensure the business is operating efficiently, effectively, and in compliance with all current regulations. Maintaining professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. Contributing to team effort by accomplishing related results as needed. Hosting registrar and regulatory inspections, as needed. Conduct internal and other independent ad-hoc audits (customer, department, process), as needed. Assisting in continual improvement and development of new procedures to foster TQM and develop current QMS (including associated technology improvement requests). This includes reviewing and continually improving customer audit process for efficiencies. Assisting with RFI/RFP coordination and completion, as needed. Building and maintaining strong relationships with new and established audit customers. Assist the Compliance & Privacy Officer and Quality Assurance Director with the creation, documentation, implementation, and evaluation of internal quality assurance programs in order to maintain accreditation. Travel domestically and internationally, as required. Complete all other tasks that are deemed appropriate for the role and assigned by the manager/supervisor. Essential skills and experience required: Innovative, proactive, and resourceful; committed to quality and continuous improvement Ability to adhere to and abide by the customer’s and company’s quality standards Exceptional problem solving/critical thinking skills and ability to learn new skills quickly Superior organizational and multi-tasking skills in order to meet commitments and deadlines Superior written and spoken communication skills in English Proficiency in Microsoft Office (Word, Excel, Outlook) Ability to work under own initiative Ability to maintain professionalism in all situations Minimum Bachelor’s degree or its equivalent Internal quality auditing qualification (ISO 9001) Previous experience overseeing sponsor audits, internal, and/or regulatory inspection audits Experience in quality assurance, CAPA, change control, deviation management, complaint handling and compliance Minimum of two years of experience in the Life Sciences industry; experience with study documentation for clinical development; and, knowledge of eClinical technologies Desired skills and experience: Experience with ISO 17100 (EN 15038) and/or ISO 27001 and/or other international standards and regulations Experience as QA in regulated industries (such as Finance, Healthcare, Pharmaceutical, CRO, Medical Device, Investigative Site, etc.) Experience with Six Sigma and other quality standards Fluency in a foreign language Able to multitask in a fast-paced environment Work well with people from a variety of different backgrounds and cultures Build relationships with customer and co-workers Can work independently and as part of a team Knowledge of clinical development phases and processes including GCP and ICH regulations and 21 CFR Part 11 requirements; experience in overseeing and training employees on TMF SOPs and regulatory requirements; and, previous experience overseeing sponsor audits, internal, and/or regulatory inspection audits TransPerfect provides equal employment opportunities 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 local law. We celebrate diversity as one of our core values and we have a clear goal: to be an inclusive workplace where a diverse mix of talented people want to come, stay and do their best work. Together with passionate, creative and collaborative colleagues, we are working to ensure accessibility is for everyone.
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