Quality Compliance Analyst II - GMP & FDA Audits

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

401k company match

Life insurance

Stock equity awards

Employee stock purchase program

Annual bonus program

Job summary

Supernus Pharmaceuticals is a biopharmaceutical company with 30+ years of CNS disease experience, currently offering a Quality Assurance & Compliance role in Rockville, MD. The position focuses on initiating and reviewing documentation, ensuring CFR/FDA alignment, and supporting audits and inspections.

The role requires a B.S. in life sciences and 2+ years in GMP/GCP/GLP environments, with strong English communication and the ability to work independently or in a team.

Qualifications

• B.S. in life sciences with 2+ years GMP/GCP/GLP experience.
• Solid understanding of GMP/GCP/GLP concepts.
• Excellent written and verbal English communication.
• Ability to work independently and in a team.

Responsibilities

• Review GMP documentation, line clearances, and raw material status.
• Support internal and external audits and regulatory inspections.
• Maintain QA compliance systems per CFR and FDA guidance.
• Assist in SOP creation and updates for QA.

Skills

GMP/GCP/GLP

English writing

Regulatory understanding

Education

B.S. in Life Sciences

Tools

Microsoft Office

Job description

Supernus Pharmaceuticals is a biopharmaceutical company with 30+ years of CNS disease experience, currently offering a Quality Assurance & Compliance role in Rockville, MD. The position focuses on initiating and reviewing documentation, ensuring CFR/FDA alignment, and supporting audits and inspections.

The role requires a B.S. in life sciences and 2+ years in GMP/GCP/GLP environments, with strong English communication and the ability to work independently or in a team.