Hiring: Quality Compliance Associate II Company: Supernus Pharmaceuticals, Inc. Location: Rockville, MD Job Posted Time: 2026-09-10 12:01:56 Employment Type: On-site Target Skills & Keywords : GCP, Microsoft Excel, Microsoft Office, Quality Assurance, Regulatory Compliance About the job Experience: •2+ years of experience in GMP, GCP, and/or GLP environment. Required Skills: •To support the Company’s Quality Assurance and compliance programs by initiating & reviewing documentation, maintaining compliance systems, performing inspections of GMP facilities, and mastering CFR and/or FDA guidance. •Major responsibilities include reviewing GMP documentation, line clearances, and status control of raw materials and finish product. Participating in internal audits, keeping the information well-organized and in a state of inspectional readiness, maintaining record integrity and security, and retrieving and auditing on-site record documentation. •Maintains GMP documentation supporting the company's facility. This activity is essential for maintaining regulatory compliance and preparing for pre-approval and general inspections by various regulatory agencies. •Maintains the QA compliance systems in accordance with U.S. regulations and internal standards. •Performs critical phase inspections related to GMP manufacturing, GCP studies, and/or GLP studies. •Performs review of documents related to GMP manufacturing, GLP studies, and/or GCP activities. •Participates in external audit of suppliers and vendors. •When appropriate, assists in all FDA inspections regarding Supernus regulated activities. Qualifications: •Position may requires prolonged sitting, prolonged standing, balancing, stooping, bending, and crouching; the ability to push, pull, drag and/or lift up to 20 pounds; normal manual dexterity and hand/eye coordination. •The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. •The worker is not substantially exposed to adverse environmental conditions. Compensation: •$71,000 - $90,000 / year •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!