GMP Compliance Analyst — CNS Drug Dev & Audits

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

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.