Quality Assistant

Job 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.

Essential Duties & 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.

Supervisory Responsibilities:

• N/A

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.

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 $45,000 to $60,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.

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.

Limitations and Disclaimer:

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.

The above job description is meant to describe the general nature and level of work performed; it is not intended as an exhaustive list of all duties, responsibilities, and required skills for the position. Employees will be required to follow any other job-related instructions and to perform other duties requested by their supervisor in compliance with Federal and State laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities necessary to perform each duty proficiently. Continued employment remains on an "at-will" basis.