Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.
Agios Pharmaceuticals is searching for a dynamic DQDI Intern to join our growing QA team. The DQDI, QA Intern will confidently manage and maintain an inspection ready GxP Computerized System Validation archive; ensuring all GxP Computerized System Validations (CSV) and supporting Standard Operating Procedures at Agios are collected and archived in a manner the maintains its data integrity throughout the systems’ life cycles. The intern will maintain the inventory of all CSV documentation, follow the ‘True Copy’ verification process moving documentation from paper to digital Veeva platform, create appropriate metadata and ensure complete collection of all records for inspection readiness.
The intern will be expected to partner with Agios Business owners, IT and QA to perform this role.
Responsibilities (including, but are not limited to)
• High attention to detail, excellent technical writing experience.
• Creates, maintains, reviews and revises procedures that ensure GxP computer systems are maintained in a validated state and in a continual state of inspection readiness with regards to cGxP.
• Collects and tracks validation deliverables and packages for GxP computer systems to ensure accessiblity throughout document life-cycle.
• Maintains archive for compliance with company policies, procedures and government guidelines, directives and regulations.
• Provides training on document management related topics.
• Supports regulatory and internal audit inspections.
• Creates and reviews routine metrics and facilitates development of appropriate action plans as well as communication with key stakeholders.
• Perform other duties as required.
Skills and Qualifications
• Knowledge of technical writing principles and quality systems.
• Proficient in MS Word, Excel, Visio, Power Point and other applications.
• Knowledge of Veeva products desired.
• Strong written and verbal communication skills.
• Ability to communicate and work independently with scientific/technical personnel.
• Current undergraduate student majoring in IT, computer science, engineering, library science or related field
• 2+ years of MS Visio and PowerPoint
• 3+ years of MS Word and Excel
• Experience in the pharmaceutical industry
• Knowledge of Good Documentation Best Practices
• Analytical thought leader with strong ability to analyze systems, data, and reports to identify creative solutions
• Excellent written and verbal communication skills
• Skilled presenter with ability to command the attention of an audience at all levels throughout an organization
· Collaborative yet decisive leader with track record for creating agile solutions