QMS Specialist I

Company: Supernus Pharmaceuticals, Inc.
Location: Rockville
Posted on: May 29, 2023

Job Description:

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. QMS Specialist I 30+ days ago Requisition ID: 2240 Job Summary:The QMS Specialist I is responsible for supporting the quality management system and GxP documentation system, including but not limited to change control; deviations/ investigation; corrective and preventive action (CAPA); training; and other GxP related documentation. -Frequent communications between departments and with other companies through phone and email will be required.

• Responsible for supporting 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; CAPAs and training.
• Maintain accuracy and consistency of External Change Control records.
• Author, review and/or revise QMS controlled documents.
• Coordinating GxP document issuance, printing, routing, review, distribution, scanning, archiving and security of storage. -
• Responsible for organizing, controlling, and maintaining the activities of the document control function. -
• Assisting in ensuring that quality documentation is controlled, change control procedures are followed, and documents are made available as defined by procedures.
• Additional responsibilities include organizing and maintaining paper copy and electronic files; using electronic database to track document activities.
• Support various other activities that pertain to QMS or as needed to support the business.
• -N/ASupervisory Responsibilities:
  • -N/AKnowledge & Other Qualifications:
    • Bachelor's Degree with o+ Years or experience or AA degree with 2+ years relative experience or High School Diploma with 4+ years relevant work experience.
    • Experience working in documentation management within the Pharmaceutical Industry a plus. -
    • Experience with managing change controls and other quality systems is preferred.
    • Experience managing manual and electronic document management systems in a regulated environment.
    • Basic knowledge of Microsoft Office software applications is mandatory.Other Characteristics:
      • Ability to work independently and as part of a team.
      • Ability to maintain high ethical standards of integrity and quality.
      • Capable of being innovative and dynamic in approach to work. -
      • 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.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.

Keywords: Supernus Pharmaceuticals, Inc., Rockville , QMS Specialist I, Other , Rockville, Maryland