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
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