Quality System Specialist I

Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym® for the treatment of patients suffering from Cushing’s syndrome, a life-threatening orphan disorder caused by excess cortisol activity. In 2022, we generated revenue of $402 million and net income of $101 million.

We have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators.  Our lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing’s syndrome, advanced ovarian cancer, castration-resistant prostate cancer and amyotrophic lateral sclerosis (“ALS”).  We plan to initiate a Phase 2b trial in patients with non-alcoholic steatohepatitis (“NASH”) by the end of this year.  Every year, we advance new molecules to the clinic.

Over the next few years, we expect to submit several new drug applications.

This position will be reporting to the Director of Quality Systems and will be responsible for supporting functions of Quality Systems operations and improvement initiatives. Responsibilities include supporting the overall Quality Systems group, including a variety of document control and records duties and onboarding/offboarding support.

Essential Duties/Tasks: 

Overall Quality Systems  

• Provide entry-level support for customer help request tickets 
• Be the primary support for quality systems help desk tickets by triaging tickets, responding to email requests, resolving tickets as needed 
• Provide users with help or instructions as applicable  
• Assist by informing team customers that need Veeva roles update 
• Provide user assistance and training on document control and record management systems, processes, and procedures 
• Manage/participate in projects/assignments that support continuous improvement efforts and department goals as assigned by Quality Management 
• Organize and maintain library of knowledge-based articles and FAQs from instructions developed by QS team members 
• Provide support for audits and regulatory agency inspections as needed 

Documents and Records 

• With direction and guidance, take lead responsibility in categorizing, organizing, filing, and developing inventory catalog of legacy records varying from personnel training records, historical audits, reports, executed protocols and records, authorizations, correspondences, or communications  
• Provide support in the document periodic review process 
• Assist with formatting documents such as SOPs, WI, Agreements using approved templates, finalizing controlled forms. Must be good with pagination, section breaks, headers and footers, attachments 
• Perform administrative tasks to maintain the document management system Veeva QualityDocs, and legacy paper-based systems 
• Promote team’s defined best practices in document control, records management, and quality events to maintain consistency and repeatability to ensure continuous improvement efforts 

Employee Onboarding/Offboarding 

• Monitor new hire notifications for managers that request new accounts in Veeva and/or ComplianceWire 
• Monitor offboarding notifications to capture required personnel changes, reporting changes and record changes in Veeva and ComplianceWire 
• Compile monthly trends to QA Management/HR to improve the overall experience onboarding new employees 

Preferred education, skills and experience:

• Experience with Electronic Document Management and Learning Management Systems and others  
• Proficient in the use of MS Office applications (Excel, Word, Visio)
• Skilled at formatting documents in accordance with templates 
• Ability to respond to email inquiries and user support questions 
• Excellent organization and communication skills 
• BA/BS degree in a scientific/technical/engineering field 
• 2 years’ experience in Pharmaceutical or life sciences

The pay range that the Company reasonably expects to pay for this position is $66,000 - $94,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of financial, health and wellness benefits, dependent on the position offered. 

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

 Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer