Quality Systems Specialist II, Document Control

As a Quality Systems Specialist II at Corcept, you'll be responsible for supporting and strengthening our document control activities. This includes providing user assistance and oversight for document management systems, organizing and updating a library of knowledge-based articles, and processing document change controls. You’ll also play a key role in communicating with users regarding Veeva QualityDocs, contributing to maintaining compliance and quality across various documents in the pharmaceutical landscape.

To qualify for the Quality Systems Specialist II role at Corcept, candidates should have a BA/BS degree in a scientific, technical, or engineering field, alongside a minimum of 6 years of experience within pharmaceutical or life sciences organizations. A strong working knowledge of GMP and GCP practices, as well as experience with document management systems, especially Veeva QualityDocs, is preferred. Excellent communication and organizational skills are also essential for collaborating across departments.

In the role of Quality Systems Specialist II, collaboration is key. You will work cross-functionally with various GxP departments, helping to ensure that document control processes are streamlined and efficient. By providing assistance and training to your colleagues, you'll help them navigate the complexities of document management systems, thereby elevating the overall quality assurance framework within Corcept.

The Quality Systems Specialist II will primarily use Veeva QualityDocs for document control and management. Strength in utilizing MS Office applications, particularly Excel, Word, and Visio, is also advantageous, as formatting and maintaining documentation according to company-wide templates is part of the role. Knowledge of electronic document management systems, including ComplianceWire LMS, is preferred to ensure thorough documentation support.

The Quality Systems Specialist II at Corcept will work in a hybrid role, requiring on-site presence three days a week in our Redwood City, California office. This setup allows for close collaboration with team members while enjoying the flexibility of remote work on off-site days. You’ll find yourself in a supportive environment where teamwork and innovation are at the core of our mission to enhance patient outcomes.

In responding to this question, highlight specific instances where you've managed document control processes, detailing the systems you've used, challenges you faced, and how you ensured compliance with regulatory standards. Providing quantifiable results or improvements you achieved can showcase your capability.

When discussing this, emphasize your attention to detail and problem-solving skills. Explain how you would identify, investigate, and escalate discrepancies, and mention any structured processes you follow to resolve these issues while ensuring adherence to SOPs.

You can showcase your understanding of document management systems by describing specific methods you've employed for maintaining version control. Talk about utilizing metadata and systematic naming conventions to track document revisions effectively.

Explain your approach to organizing tasks, such as using project management tools or techniques like Eisenhower’s Matrix, to prioritize activities. Share experiences that demonstrate your ability to balance competing priorities while maintaining quality.

Your answer should reflect a solid understanding of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). You can explain their significance in the pharmaceutical industry and share practical examples of how you've applied these principles in your previous roles.

This is your chance to showcase your project management skills. Pick a project where your contributions led to significant improvements in document quality or control processes and discuss the strategies you applied to reach your goals.

Discuss your experience with Veeva QualityDocs, providing specific examples of how you've utilized the system for document management. Emphasize your proficiency in its workflows, lifecycles, and any training or support you've provided to colleagues.

Discuss the steps you take to ensure all document revisions are compliant with relevant regulations. Mention your understanding of regulatory standards and how you’ve successfully implemented standardized processes to manage changes.

Highlight the importance of training in ensuring that all team members understand and utilize document control systems effectively. You can cite examples from your experience where training contributed to improving processes and compliance.

Share your approach to fostering communication among diverse teams. This could include regular update meetings, clear email communication, and utilizing collaborative tools to ensure everyone is on the same page regarding document changes or updates.