Document Control Specialist, Quality Systems

The Document Control Specialist at Mirum Pharmaceuticals is responsible for the administration and maintenance of the electronic document management system (EDMS). This includes supporting the Document Control, training, and eQMS teams, driving continuous improvement activities, assisting with document migration, and facilitating periodic reviews of controlled documents to ensure compliance with regulatory standards.

To be successful in the Document Control Specialist role at Mirum Pharmaceuticals, candidates should possess a Bachelor’s Degree and have over 3 years of experience in the pharmaceutical industry, particularly in a Quality Assurance capacity. Familiarity with Veeva QualityDocs or eQMS, alongside a solid understanding of compliance regulations such as 21 CFR Part 11, is also essential.

The Document Control Specialist plays a crucial role in supporting audits and Regulatory Health Authority inspections at Mirum Pharmaceuticals. This involves ensuring that all necessary documentation is properly maintained and accessible for review, and helping the team demonstrate compliance with established quality management systems and practices.

In the role of Document Control Specialist at Mirum Pharmaceuticals, you will utilize various software programs and tools, notably Veeva QualityDocs and the electronic document management system (EDMS). Proficiency in Microsoft Office Suite applications like Excel, PowerPoint, Word, and Outlook is also required for day-to-day tasks.

A Document Control Specialist at Mirum Pharmaceuticals not only gets to work with a talented team but also has ample opportunities for professional growth. Through hands-on experience with regulatory compliance, continuous improvement projects, and system training, you can advance your expertise and take on more challenging responsibilities within the quality assurance domain.

Definitely! When discussing your experience with electronic document management systems, it’s beneficial to highlight specific systems you've used and how you've contributed to their administration. Be sure to explain the types of documents you handled and any challenges you overcame while maintaining compliance.

You should focus on your systematic approach towards compliance, like regular audits, training sessions, and process reviews. Use examples from past experiences to illustrate your commitment to maintaining documentation accuracy and adherence to regulatory standards.

In your response, consider mentioning your proactive nature in identifying inefficiencies and proposing actionable improvements. Share past experiences where your suggestions have yielded positive changes in document control processes, emphasizing collaboration with colleagues to implement these changes.

It’s vital to convey a solid understanding of Good Documentation Practices, referring to principles like ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate). Elaborate on how these principles guide your document control efforts and ensure compliance within your past roles.

When addressing this question, discuss your techniques for imparting knowledge effectively, such as creating engaging training materials and offering hands-on workshops. Share how you assess understanding and adapt training methods according to the audience's needs.

Be specific about your contributions during a particular audit—whether it was preparing documentation, coordinating with team members, or ensuring compliance with regulatory expectations. Illustrate your familiarity with audit protocols and your ability to remain organized under pressure.

Talk about your previous experience in developing training resources, such as manuals, guides, or instructional videos, and their impact on employee performance. Highlight how you ensure materials are user-friendly and effectively convey important information.

Think of a specific situation where a document control issue arose, and explain it clearly. Describe the steps you took to analyze the problem, the solutions you implemented, and the positive outcomes that resulted from your intervention.

Communication is critical in this role. Discuss how you engage with various stakeholders, from training new employees to collaborating with quality assurance teams. Provide examples of how effective communication has helped mitigate issues and streamline document-related processes.

For this question, you should demonstrate your knowledge of relevant regulations such as 21 CFR Part 11 and the GxPs. Discuss how awareness of these regulations informs your document control practices and your commitment to maintaining compliance with these critical standards.