Agios (agios.com) is a biopharmaceutical company focused on providing medicines for some of the world’s most challenging diseases. We’re committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the PK platform. We are leading the way in advancing PKR activation for hemolytic anemias, including pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease, and have demonstrated a strong commitment to these patient communities. We continue to foster a productive research engine that yields new insights and potential therapeutic approaches. We’re a company that cares about our work, each other, and the people who are counting on us the most. We’re inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results. We’re driven to be our best selves, together, so we can reach for the Other Side of Possible.
Agios Pharmaceuticals is searching for a dynamic DQDI Co-op to join our growing QA team. The DQDI, QA Co-op 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 Co-op 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 Co-op 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 Co-opal 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.
- Seeking bachelor degree 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
Reporting to: Sr. Manager, Digital Quality Data Integrity, QA
Location: Agios, 88 Sidney Street, Cambridge, MA 02136