Quality Compliance Associate II — GMP & CFR Audits

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

Benefits offered by this job

Health insurance

401k company match

Stock equity awards

Employee stock purchase plan

Discretionary annual bonus

Job summary

Supernus Pharmaceuticals, Inc. is seeking a QA professional to support documentation review and compliance programs. The role includes maintaining GMP systems, conducting inspections, and aligning with CFR and FDA guidance to ensure regulatory readiness.

The ideal candidate will have a B.S. in life sciences and 2+ years in GMP/GCP/GLP environments, with strong English communication skills and the ability to work in a fast-paced setting.

Qualifications

• B.S. in a life sciences discipline and 2+ years in GMP, GCP, or GLP environments.
• Understanding of GMPs, GCPs, and GLPs and their applications to diverse problems.
• Strong written and verbal English communication; a second language is a plus.

Responsibilities

• Review GMP documentation, line clearances, and material status.
• Maintain GMP documentation and readiness for inspections.
• Support QA compliance systems per US regulations and internal standards.
• Assist in FDA inspections and internal audits as needed.
• Initiate or revise QA SOPs; stay current with CFR and FDA guidance.

Skills

GMP knowledge

GCP knowledge

GLP knowledge

Technical writing

English proficiency

Education

B.S. in life sciences

Tools

Microsoft Office

Job description

Supernus Pharmaceuticals, Inc. is seeking a QA professional to support documentation review and compliance programs. The role includes maintaining GMP systems, conducting inspections, and aligning with CFR and FDA guidance to ensure regulatory readiness.

The ideal candidate will have a B.S. in life sciences and 2+ years in GMP/GCP/GLP environments, with strong English communication skills and the ability to work in a fast-paced setting.