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
We are a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. It was founded in 2005, and is headquartered in Rockville, Maryland, USA, with a workforce of 201-500 employees. Its website is http://www.supernus.com.
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