The Quality Specialist II of Quality Compliance will be a core team member of the Quality Compliance department to perform day-to-day Quality operations as instructed and trained to support success of the clinical studies sponsored by Corcept.
The Specialist II, Quality Compliance supports the Clinical Quality Compliance function by assisting with GCP compliance activities, vendor oversight processes, audit program administration, quality system activities, inspection readiness efforts, and continuous improvement initiatives. This role partners closely with Clinical QA, Clinical Operations, Pharmacovigilance, Biometrics, and external vendors to help maintain compliance with applicable GCP regulations, industry standards, and internal procedures. The Specialist will support the planning, coordination, execution, and follow-up of audits and quality system activities and may participate in audits under the guidance of experienced QA auditors.
This is a hybrid role typically requiring on-site presence at least 3 days per week.
Responsibilities:- Support vendor qualification, monitoring, and requalification activities, including documentation reviews and risk assessments
- Coordinate vendor, and internal GCP audits in accordance with the annual audit plan
- Support audit logistics, scheduling, documentation management, agenda preparation, and audit communications
- Assist in preparing audit reports, tracking observations, and monitoring audit-related CAPAs through closure
- Maintain audit records, audit schedules, and audit metrics within Veeva QMS and other quality systems
- Participate in GCP audits as an audit team member and develop auditing skills through training, mentorship, and on-the-job experience
- Assist with vendor performance monitoring and tracking of key vendor quality metrics
- Support quality agreement development, revision, execution, and periodic review activities
- Participate in inspection readiness initiatives and continuous improvement projects designed to strengthen GCP compliance across the organization
- Assist in the development and maintenance of quality metrics, reports, and dashboards
- Identify opportunities for process improvement and support implementation of quality and compliance initiatives
- Maintain awareness of evolving GCP regulations, industry guidance, and best practices
Preferred Skills, Qualifications and Technical Proficiencies:- Excellent in basic Microsoft Office applications (Word, Excel, PowerPoint) is required
- Basic understanding of GCP and best industry practices
Preferred Education and Experience:- A BA/BS degree in biological sciences, pharmacy, or a related field is required
- 2-4 years' experience in clinical-stage pharmaceutical companies or a related field
Travel- Up to 25% following certification as auditor
The pay range that the Company reasonably expects to pay for this headquarters-based position is $90,000 - $115,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
