To provide administrative support to Supernus quality systems and GxP documentation. The Sr QMS Specialist is responsible for serving as the Veeva System Administrator and maintaining the quality management system and GxP documentation system, including but not limited to change control; deviations/ investigation/ OOS; corrective and preventive action (CAPA); training; complaints/ adverse events; and other GxP related documentation. Frequent communications between departments and with other companies through phone and email will be required.
Essential Duties & Responsibilities
* Responsible for the administration of the quality and document management systems for the creation, maintenance and control of GxP documents, which may include but is not limited to, change controls; deviations/investigations/OOS; CAPAs; training records; complaints/adverse events records; batch production, release and stability testing documentation; internal/external audits; supplier management.
* Serve as System Administrator of the EDMS (electronic document management system) /QMS system (Veeva).
* Identifies and implements any changes necessary to ensure and maintain the effectiveness of the quality management system using policies and procedures to adhere to regulatory requirements.
* Supports the execution of deviations, investigations, CAPA and change control systems including assurance of compliance to associated procedures.
* Maintains GxP documentation and ensures that the documents are organized in an efficient manner for ease of retrieval during an audit or inspection, and for routine access.
* Responsible for monitoring and analyzing the impact of new regulations, standards, and procedures throughout the organization
* Interfacing with other departments to ensure that the Quality System is implemented and effective
* Responsible for supporting regulatory inspections / being part of team that supports inspections.
* Responsible for liaising suppliers to obtain information, documentation, or data to ensure documentation files are complete.
* Supports the collection of key quality and compliance metrics
* Prepares and assesses procedures, forms, reports, and other documentation for review and approval by others.
* Supports the product quality complaint program as a back-up resource.
* Other duties as assigned.
Non-Essential Duties & Responsibilities:
Knowledge & Other Qualifications:
* Bachelor's degree or AA degree and 4+ year's applicable experience.
* Experience with good documentation practices is preferred.
* Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
* Experience managing manual and electronic document management systems in a regulated environment.
* Proficient knowledge of Microsoft Office software applications is mandatory.
* Strong communication and technical writing skills.
* Ability to manage multiple tasks and meet goals and timelines.
* 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.
Physical Requirements / Work Environment
* 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
Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.
- Change Control
- Corrective And Preventive Action (Capa)
- Document Management Systems