Senior Quality Compliance Associate
Supernus Pharmaceuticals, Inc. - Rockville, MD
Hiring: Senior Quality Compliance Associate Company: Supernus Pharmaceuticals, Inc. Location: Rockville, MD Job Posted Time: 2026-09-16 12:01:56 Target Skills & Keywords : GCP, Microsoft Office, Quality Assurance About the job Experience: •4+ years of experience in GMP and/or GCP environment. Required Skills: •To perform various quality assurance activities including but not limited to maintaining the compliance systems in accordance with U.S. and internal regulations and standards. •May manage and perform internal and external GxP audits, GCP and GLP audits, investigation site audits and internal bioanalytical audits as directed by management. •May provide oversight of suppliers (CMOs, distributors, laboratories, GMP service providers, GLP and GCP vendors etc.) as directed by management. •Reviews and approves internal and external deviations, investigations, OOS, CAPA, and change controls. •Reviews documentation related to GCP and GLPs. •Reviews GxP records (e.g., process validation, equipment qualification, software validation) for compliance with FDA regulations, internal company standards, and others as applicable. •May review analytical method validation protocols, technical reports, stability protocols and respective reports. •May review and approve clinical and bioanalytical protocols and reports. Qualifications: •Position may require 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: •$90,000 - $108,000 / 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!