Quality Assurance Associate I

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with over 30 years of experience in developing products for CNS diseases. The Quality Assurance Associate I will support the company's Quality Assurance and compliance programs by initiating and reviewing documentation, maintaining compliance systems, and performing inspections of GMP facilities.

Responsibilities

• 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
• 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 SOPs 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

Skills

• 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 language
• Ability to work independently, as well as ability to function as a team player
• Ability to accept personal accountability for successful job performance
• 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
• 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
• 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 standards of integrity and quality
• Ability of having an innovative and dynamic approach to work
• A self-starter able to work independently but comfortable working in a team environment
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others
• Capable of performing other duties as assigned by Management
• Authorized to legally work in the United States without visa sponsorship
• 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
• A second language is a plus
• Familiar with internal and external auditing is a plus

Benefits

• Opportunity to participate in employee stock purchase programs
• Performance-based bonus programs

Company Overview