Quality Assistant

Role Summary

The Quality Assistant is responsible for the entry of records into the electronic quality management system (eQMS) and management of records in a limited access room. The Quality Assistant will be primarily involved in ensuring records are accurately entered into the eQMS and on-site records are maintained according to record retention policies. This role will ensure integrity, consistency in documentation, and support to internal and external stakeholders.

Responsibilities

• Accurately entering records into the eQMS (i.e., external change controls, customer complaints, external deviations).
• Organize, file, and categorize records according to established procedures and guidelines in the records room.
• Update and manage the records management system with current record status and retention period.
• Coordinate the destruction of records in compliance with the Supernus Record Retention Schedule and legal requirements.
• Coordinating GxP documentation storage and archival.
• Other duties as assigned.

Knowledge & Other Qualifications

• Associates degree and one year of relevant experience or a High School diploma and three years of relevant experience.
• Previous experience in document management or related field a plus.
• Experience working in eQMS systems is preferred.
• Proven experience managing manual and electronic document management systems in a regulated environment.
• Strong attention to detail and excellent organizational skills.
• Basic knowledge of Microsoft Office software applications is mandatory.
• Excellent verbal and written communication skills.

Other Characteristics

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability to have 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.

Physical Requirements/Work Environment/Travel Requirements

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• 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.