GMP Quality Compliance Specialist II

Supernus Pharmaceuticals Inc; Rockville (MD); On-site; USD 71,000 - 90,000; Full time

Benefits offered by this job

Health benefits

401k match

Paid time off

Life insurance

Job summary

Supernus Pharmaceuticals is seeking a Quality Assurance professional to support compliance programs by reviewing GMP documentation, maintaining compliance systems, and mastering CFR/FDA guidance. The role involves inspecting GMP facilities, participating in internal audits, and ensuring record integrity and inspection readiness.

Responsibilities include review of GMP docs, line clearances, audits of suppliers, and assisting FDA inspections.

Qualifications

• 2+ years of GMP, GCP, or GLP experience in pharma/biotech settings.
• Strong written and spoken English communication skills.
• Ability to work independently and as part of a team with accountability.
• Attention to detail in documentation, record integrity and audit readiness.
• Familiarity with CFR and FDA guidance is a plus.

Responsibilities

• Review GMP documentation, line clearances and raw material status.
• Maintain GMP documentation and support regulatory inspections readiness.
• Support internal and external audits and supplier audits.
• Assist in preparing, executing and following up on audit activities.
• Develop or revise QA SOPs and ensure CFR/FDA alignment.

Skills

GMP knowledge

GCP knowledge

GLP knowledge

Education

B.S. in life sciences

Tools

Microsoft Office Suite

Job description

Supernus Pharmaceuticals is seeking a Quality Assurance professional to support compliance programs by reviewing GMP documentation, maintaining compliance systems, and mastering CFR/FDA guidance. The role involves inspecting GMP facilities, participating in internal audits, and ensuring record integrity and inspection readiness.

Responsibilities include review of GMP docs, line clearances, audits of suppliers, and assisting FDA inspections.