Quality Systems Specialist

This role is a core member of the Quality Systems team and works on activities and tasks that support various Quality Systems projects. This is a supporting role that requires an adaptable and fast learner that works under the guidance and direction of Quality Systems staff across systems used to manage controlled documents, training, and quality events. This position reports to the Sr. Manager of Document Control and Training.

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

Responsibilities:

• Ability to promptly respond to email inquiries and user support questions using ticketing systems like Zendesk
• Support the Quality Systems team on a variety of tasks or projects that span across document control, training, inspection management and other quality event modules (including but not limited to deviations, CAPAs, and change controls)
• Assist with training attendance records and cataloging and filing activities, as well as uploading completed forms into the Learning Management System (LMS)
• Assess training qualification materials, including but not limited to SOPs and work instructions, ensuring they are appropriately added into training curricula across various GxP departments
• Organize, file, and catalog legacy-controlled records in Document Control’s cabinets
• Assist with uploading and certifying documents into Veeva QualityDocs to align legacy processes with current ones
• Provide support for Corcept’s continuous improvement efforts of the Quality Management System (QMS)
• 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 control, etc.)
• Capture detailed meeting minutes, action items, and key decisions, and circulate
• Assist in drafting internal communications for events and status reports
• Coordinate and schedule lunch and learn training sessions, office hours, and other events

Preferred Skills, Qualifications and Technical Proficiencies:

• Experience with Electronic quality systems (Veeva QualityDocs and Veeva QMS) and Learning Management Systems (ComplianceWire LMS)
• Proficient in the use of MS Office applications (Excel, Word, Visio, Teams)
• 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 5 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 $86,300 - $101,500; 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.