Quality Systems & Document Control Specialist

Civica; Petersburg (VA); Presencial; USD 55.000 - 85.000; Jornada completa

Descripción de la vacante

Civica, Inc. in Petersburg, Virginia is seeking a Quality Systems Associate - Document Control to maintain the document control system, ensure CGMP compliance, and support training and change control activities.

You will act as site SME, manage change requests, and help drive quality across the organization. This role requires a bachelor's degree and at least 2 years in document control within a regulated industry; experience with Veeva or EDMS is preferred; strong organization and communication

Formación

• Bachelor’s degree with a minimum of 2 years of experience or a combination of 8 years of education and experience in document control and training within a regulated industry.
• Experience in document control and training administration within the Pharmaceutical Industry.
• Experience writing and/or revising Standard Operating Procedures (SOPs).
• Familiarity with electronic document management systems (EDMS) such as Veeva.

Responsabilidades

• Maintain Civica Petersburg's Document Control System and act as SME on document control.
• Manage Document Change Requests and Document Change Controls.
• Coordinate document control and training timelines.
• Oversee Periodic Review Timeliness and document revisions.
• Perform impact assessments for document change controls.
• Assist in training verification and true copy verification.

Conocimientos

Document control

SOP writing

Organization skills

Communication skills

Autonomy

Problem solving

Educación

Bachelor's degree

Herramientas

Veeva

Descripción del empleo

Civica, Inc. in Petersburg, Virginia is seeking a Quality Systems Associate - Document Control to maintain the document control system, ensure CGMP compliance, and support training and change control activities.

You will act as site SME, manage change requests, and help drive quality across the organization. This role requires a bachelor's degree and at least 2 years in document control within a regulated industry; experience with Veeva or EDMS is preferred; strong organization and communication