Quality Systems Specialist II

This position reports to the Sr. Manager of Document Control and Training and is responsible for supporting and strengthening document control activities at Corcept. This role will work with the group and support document control processes in Veeva QualityDocs (QDS). This role will be highly cross-functional and will collaborate with all GxP departments.

This is a hybrid position, requiring on-site presence 3 days per week.

Responsibilities:

• Provide user assistance, training, and oversight on document control and record management systems, processes, and procedures
• Organize, maintain, and continuously update a library of knowledge-based articles and FAQs from instructions developed by Quality Systems team members
• Act as first point of contact for all Corcept users in Veeva QDS
• Strong working knowledge of GMP and GCP practices and how they might apply to Corcept SOPs, work instructions, and controlled records
• Strong grasp of different document types such protocols, reports, controlled records (development, clinical, and commercial), vendor/supplier audit documentation, and clinical study level documents
• Perform administrative tasks to maintain both the electronic document management system (Veeva QualityDocs) and legacy paper-based systems, including but not limited to cataloging on-site documents, executing the certified copy process, and helping maintain a global glossary list
• Process document change controls (DCCs) for broad variety of controlled documents
• Initiate the document periodic review process across various SOP owners and convert data for pending and overdue periodic review tasks into reportable metrics
• Identify and escalate gaps and discrepancies in controlled documents and the processes that govern them (e.g. document formatting, SOP style consistency, clear and concise wording, document change controls, etc.)
• Enforce guidelines on document metadata and company processes to maintain consistency and uniformity in Veeva QDS
• Strong understanding of version and revision control for a variety of controlled document types
• Assist users with formatting documents such as SOPs, work instructions, or quality agreements using approved templates and finalizing controlled forms. Proficient in Microsoft Word formatting including styles, pagination, section breaks, headers and footers, table properties, attachments, and page layouts
• Fluent in Veeva QDS workflows, lifecycles, and audit trails
• Working knowledge of various controlled documents and their purpose across a pharmaceutical drug development cycle
• Strong working knowledge of change controls, deviations, investigations, CAPAs, complaints, and internal/external audits. Experience with Veeva QMS quality event modules is preferred
• Support/execute processes for filing, organizing, and cataloging legacy paper documents
• Strong grasp of GxP training program requirements, including role-based training, curricula hierarchy, instructor led training, and training assignments
• Ability to promptly respond to email inquiries and user support questions using ticketing systems like Zendesk

Preferred Skills, Qualifications and Technical Proficiencies:

• Experience with Electronic Document Management and Learning Management Systems (specifically, Veeva Quality suite and ComplianceWire LMS)
• Proficient in the use of MS Office applications (Excel, Word, Visio, Teams)
• Skilled at formatting documents in accordance with templates and capable of producing controlled forms
• Excellent organizational skills and the ability to manage multiple competing tasks
• Excellent communication skills with the ability to collaborate with a wide range of stakeholders in various departments

Preferred Education and Experience:

• BA/BS degree in a scientific/technical/engineering field
• Minimum of 6 years of experience in pharmaceutical or life sciences organizations

The pay range that the Company reasonably expects to pay for this headquarters-based position is $105,300 - $123,900; 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.