Quality Compliance Associate II

Scorpion Therapeutics; Rockville (MD); On-site; USD 90,000 - 120,000; Full time

Job summary

Supernus Pharmaceuticals in Rockville, MD, seeks a Quality Assurance Specialist to support GMP compliance across documentation review, facility inspections, and audit readiness within CNS drug development. The role emphasizes regulatory alignment with CFR/FDA guidance and readiness for upcoming inspections.

The ideal candidate has a life sciences background and hands-on GMP/GCP/GLP exposure, plus strong technical writing skills to ensure precise, compliant documentation and processes.

Qualifications

• B.S. in life sciences with practical GMP/GCP/GLP experience.
• 2+ years in GMP/GCP/GLP environments and strong regulatory knowledge.
• Proficiency in technical writing and documentation practices.

Responsibilities

• review GMP documentation
• participate in internal and external audits
• maintain compliance systems according to CFR/FDA guidance
• support inspection preparedness

Skills

GMP/GCP/GLP knowledge

Technical writing

Education

B.S. in life sciences

Job description

Role

Quality Assurance Specialist supporting GMP compliance at Supernus Pharmaceuticals, focused on documentation review, facility inspections, and audit readiness within CNS drug development.

Responsibilities

• review GMP documentation
• participate in internal and external audits
• maintain compliance systems according to CFR/FDA guidance
• support inspection preparedness

Qualifications

• B.S. in life sciences
• 2+ years in GMP/GCP/GLP environments
• strong understanding of regulatory standards
• proficiency in technical writing

Preferred

• familiarity with pharmaceutical equipment
• validation concepts
• auditing experience

High-Value

• GMP compliance
• documentation oversight
• CFR/FDA guidance
• CNS therapeutic focus
• inspection support

Work Setup

on-site in the U.S., no travel specified.