Quality Compliance Associate II

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

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.
• When appropriate, assists in internal audit procedures at Supernus.
• Assists in the preparation, execution, report, and follow-up of internal and external audits.
• Supports senior staff members in their responsibilities and tasks.
• Initiates new SOP’s or revises existing SOP’s for the QA department as needed.
• Stays current with CFR and FDA guidance documents to ensure that Supernus compliance policies are up to date.
• Other duties as assigned.
• May review SOP’s subject to QA review.
• May serve as a backup for training activities, regarding general compliance to the QA department responsibilities.
• May serve as a backup for documentation management activities, regarding general compliance to the QA department responsibilities and maintaining company’s SOP systems.

• N/A

• B.S. in a life sciences discipline, with 2+ years of experience in GMP, GCP, and/or GLP environment.
• Understanding of GMPs, GCPs, and/or GLPs, and their application to a wide variety of problems and situations.
• Strong communication and technical writing skills in English language. A second language is a plus.
• Ability to work independently, as well as ability to function as a team player. Ability to accept personal accountability for successful job performance, and ability to initiate and offer suggestions aimed at improving service to our customers.
• Ability to work efficiently and accurately to meet set goals and timelines, and ability to pay attention to detail.
• Ability to work in a fast paced and flexible work environment where priorities can change.
• Familiar with pharmaceutical equipment, utilities, and validation concepts.
• Familiar with internal and external auditing is a plus.
• Excellent interpersonal and communication skills in English language (writing, speaking, and comprehension).
• Computer literacy with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF.

• Ability to work independently and as part of a team and maintain high ethical…