Senior Specialist, Quality Operations 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

BA/BS or master’s degree in science, engineering or related field
6+ years in Quality Assurance
Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processes
Knowledge in the application of 21CFR211, global cGMP regulations and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery and control of pharmaceutical products
Ability to work independently and communicate effectively with project team members, management groups and suppliers
Works well in a project team environment with solid problem analysis and decision-making ability
Ability to author, review and approve SOPs and other controlled documentation for compliance with applicable regulations
Advanced Microsoft Office application skills (Word, Excel, PowerPoint)
Travel required
Currently authorized to work in the United States on a full-time basis

Responsibilities

Support various Chemistry, Manufacturing and Controls (CMC) projects
Work cross-functionally with the CMC group to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations
Interface with CMOs/CTLs to provide QA oversight of routine manufacturing and packaging activities
Perform product disposition/batch release
Review and approve master batch records and executed batch records
Review and approve quality control records (e.g., COAs, specifications, analytical protocols and reports, stability protocol and reports, etc.)
Review and approve manufacturing records (e.g., validation/development/transfer protocols and reports etc.)
Review and approve quality events (e.g., deviations, change controls, CAPAs and complaints)
Ensure timely complaint initiation, investigation/analysis and closure
Support quality audit of suppliers, CTLs and CMOs

Skills

Key technologies and capabilities for this role

CMCQuality AssuranceProduct DispositionBatch ReleaseBatch Record ReviewQuality Control RecordsManufacturing RecordsDeviationsChange ControlsCAPAValidation ProtocolsStability ProtocolsContract Manufacturing Oversight

Questions & Answers

Common questions about this position

What education and experience are preferred for this role?

A BA/BS or master’s degree in science, engineering or related field is preferred, along with 6+ years in Quality Assurance and knowledge of 21CFR211, global cGMP regulations, and ICH guidelines.

What are the key skills required for the Senior Specialist, Quality Operations position?

Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing, ability to work independently and communicate effectively, solid problem analysis and decision-making in teams, and proficiency in authoring/reviewing SOPs and advanced Microsoft Office skills are required.

Is travel required for this position?

Yes, travel is required for this role.

What is the salary or compensation for this role?

This information is not specified in the job description.

What kind of experience makes a strong candidate for this position?

Candidates with 6+ years in Quality Assurance, strong knowledge of cGMP regulations, analytical chemistry, and pharmaceutical manufacturing, plus experience reviewing batch records, quality events, and working with CMOs 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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