Job Description

Company Overview

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. We currently have 9 products in the market that are making a real impact on patient outcomes.

Job Summary

The Quality Assurance Associate I will support the companys Quality Assurance and compliance programs by initiating & reviewing documentation, maintaining compliance systems, performing inspections of GMP facilities, and mastering CFR and/or FDA guidance.

Essential Duties & Responsibilities

• Review GMP documentation, line clearances, and status control of raw materials and finished product.
• Participate in internal audits, keep the information well?organized and ready for inspection, maintain record integrity and security, and retrieve and audit on?site record documentation.
• Maintain GMP documentation supporting the companys facility, essential for regulatory compliance and preparing for pre?approval and general inspections by regulatory agencies.
• Maintain the QA compliance systems in accordance with U.S. regulations and internal standards.
• Perform critical phase inspections related to GMP manufacturing, GCP studies, and/or GLP studies.
• Review documents related to GMP manufacturing, GLP studies, and/or GCP activities.
• Assist in all FDA inspections regarding Supernus regulated activities when appropriate.
• Assist in internal audit procedures at Supernus when appropriate.
• Assist in the preparation, execution, report, and follow?up of internal and external audits.
• Support senior staff members in their responsibilities and tasks.
• Initiate new SOPs or revise existing SOPs for the QA department as needed.
• Stay current with CFR and FDA guidance documents to ensure that Supernus compliance policies are up to date.
• Other duties as assigned.

Non?Essential Duties & Responsibilities

• May review SOPs 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 the companys SOP systems.

Knowledge & Other Qualifications

• B.S. in a life sciences discipline, with 0+ 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. A second language is a plus.
• Ability to work independently and as a team player. Accept personal accountability for successful job performance and offer suggestions to improve service to our customers.
• Ability to work efficiently and accurately to meet set goals and timelines, and 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 (writing, speaking, and comprehension).
• Computer literacy with proficiency in Microsoft Office including Word, Outlook, Excel, and Adobe PDF.

Other Characteristics

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Innovative and dynamic approach to work.
• A self?starter able to work independently but comfortable working in a team environment.
• Consistently exhibit Supernus values in interactions with employees at all levels, vendors, customers, and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements / Work Environment / Travel Requirements

• Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, and crouching; ability to push, pull, drag and/or lift up to 20 pounds; normal manual dexterity and hand/eye coordination.
• Required close visual acuity to perform activities such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; extensive reading.
• No substantial exposure to adverse environmental conditions.

Compensation

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $52,000 to $67,000. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance?based bonus programs.

Equal Opportunity Employer

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.

Legal Notice

Equal Opportunity Employer
For further information, please review the Know Your Rights notice from the Department of Labor.

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