Quality Systems Specialist

The main responsibilities of a Quality Systems Specialist at Corcept include managing document control, assisting with training attendance records, cataloging operational activities, and supporting quality event modules such as deviations and CAPAs. This role involves collaborating with various departments and maintaining organized records in compliance with quality systems.

For the Quality Systems Specialist position at Corcept, candidates should have a BA/BS degree in a scientific or technical field and a minimum of 5 years of experience in pharmaceutical or life sciences organizations. Familiarity with electronic quality systems and Learning Management Systems is preferred, along with strong organizational and communication skills.

Corcept supports its Quality Systems team by facilitating collaboration across departments and providing tools like Veeva QualityDocs and ComplianceWire LMS. The company emphasizes continuous improvement initiatives, allowing team members to contribute to the enhancement of the Quality Management System (QMS).

Desirable skills for a Quality Systems Specialist at Corcept include proficiency in MS Office applications, excellent organizational skills, strong communication abilities, and adaptability to manage multiple tasks efficiently. Experience with electronic quality systems will also be beneficial.

The work environment for a Quality Systems Specialist at Corcept is collaborative and innovative. This hybrid position requires on-site presence three days a week, fostering teamwork while also offering flexibility to work remotely. You will be involved in meaningful projects that impact patient care.

When answering this question, be sure to highlight specific experiences you've had with document control systems, particularly in relation to quality management in a life sciences context. Mention any particular software you've used, challenges faced, and how you ensured compliance and accuracy in managing controlled documents.

To effectively answer, share your method for assessing task urgency and importance. Discuss your experience in balancing competing tasks, possibly by using organizational tools or communication with supervisors to ensure alignment with team objectives.

Highlight your experience with Good Practice (GxP) regulations and your familiarity with related processes. Discuss specific actions you’ve taken, such as conducting audits, training sessions, or quality checks, to demonstrate commitment to compliance.

For this question, discuss your philosophy on training and developing others. Highlight your experience in creating training materials, ensuring understanding of Standard Operating Procedures (SOPs), and fostering an environment of continuous learning among team members.

Tell a story of a specific quality improvement project where you played a significant role. Discuss your contributions, the challenges you overcame, and the measurable impact of the project on the organization's quality management processes.

When answering, convey your knowledge about Corcept's mission, particularly its focus on discovering and developing cortisol modulators for serious diseases. This shows your enthusiasm for their work and aligns your values with the company’s goals.

Discuss your process for identifying, escalating, and rectifying discrepancies in controlled documents. Emphasize your attention to detail and collaborative efforts with team members to ensure all documentation meets regulatory and internal standards.

Share specific experiences with electronic quality systems, particularly Veeva QualityDocs or similar platforms. Discuss how you've utilized these systems for effective quality management, training, or document control in past roles.

Provide an example showcasing your communication skills. Detail the situation, how you approached sharing the difficult information, and any strategies you used to ensure understanding and maintain a positive working relationship.

Articulate your passion for quality systems and how they relate to improving patient outcomes. Share personal motivations, such as a commitment to accuracy, compliance, and the impact that quality processes have on the broader healthcare community.