Senior Specialist, Quality Systems Technology (QST) at Corcept Therapeutics

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Advanced proficiency with core quality processes in Veeva and ComplianceWire, including document control, CAPA, deviations, change control, and training
Experience writing and revising SOP, Work Instructions, and related documents
Demonstrated experience supporting validation of computerized systems and processes
Working knowledge of regulations within the pharmaceutical industry, particularly GMP, GCP, and 21 CFR Part 11/EU Annex 11
Effective communication and interpersonal skills; capable of training both technical and non-technical users in system functionality
Customer-focused and able to prioritize tasks when presented with competing priorities with internal stakeholders
BA/BS degree in a scientific/technical/engineering field, or equivalent combination of education and experience (preferred)

Responsibilities

Administer and execute technical processes in Veeva Quality (QMS and QualityDocs) ensuring accuracy of data, supporting user input, enacting minor configuration updates, and providing validation support
Provide support for the Learning Management System (ComplianceWire)
Support validation activities by running test scripts for Veeva Quality (QMS and QualityDocs) and ComplianceWire
Monitor system performance and address technical issues and user needs promptly to maintain system integrity and process efficiency
Identify process and system inefficiencies and recommend improvements
Provide basic guidance and support to Corcept personnel on system functionality, including training of new users
Contribute to inspection readiness efforts by supporting logistics, generating reports, and responding to requests

Skills

Key technologies and capabilities for this role

Veeva QualityQMSQualityDocsComplianceWireLMSDeviationsChange ControlCAPADocument ManagementTraining ManagementSystem AdministrationSecurity SettingsCompliance ReportingSystem TestingConfigurationValidation

Questions & Answers

Common questions about this position

Is this a remote role or does it require office presence?

This is a hybrid role that requires on-site presence at least 3 days per week.

What skills are required for the Senior Specialist, Quality Systems Technology role?

Advanced proficiency with core quality processes in Veeva and ComplianceWire is required, including document control, CAPA, deviations, change control, and training. Experience writing and revising SOPs, Work Instructions, and related documents is also needed.

What is the salary for this position?

This information is not specified in the job description.

What are the main systems I'll be working with in this role?

The role involves supporting and optimizing Veeva Quality (QMS & QualityDocs) and ComplianceWire (LMS), including technical tasks for deviations, change control, CAPA, document management, and training.

What makes a strong candidate for this QST role?

Candidates with advanced proficiency in Veeva Quality and ComplianceWire processes, experience with quality systems like CAPA and deviations, and the ability to handle validation, configuration, and cross-functional collaboration will stand out.

Corcept Therapeutics

Develops cortisol modulators for medical conditions

About Corcept Therapeutics

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health issues. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by too much cortisol. Korlym was approved by the FDA in 2012 and is the first medication specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 unique cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.

Menlo Park, CaliforniaHeadquarters

1998Year Founded

$39.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Flexible Work Hours

Risks

Teva's antitrust lawsuit could lead to legal expenses and market share loss.

Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.

Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

Differentiation

Corcept specializes in cortisol modulation, a niche with few direct competitors.

Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.

Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

Upsides

Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.

Advancements in drug delivery systems could enhance Corcept's product efficacy.

The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

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