GxP Document Control Specialist

Civica, Inc.; Petersburg (VA); Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

Civica, Inc. seeks a skilled Quality Systems Associate – Document Control at its Petersburg, Virginia site.

You will ensure the document control system aligns with regulatory expectations, manage change controls, and support training and SQMS processes to keep quality medicines flowing to patients. The role emphasizes cGMP compliance, cross-functional collaboration, and continuous improvement in a fast-paced pharmaceutical setting.

Formación

• Bachelor’s degree or equivalent with a mix of education and experience in doc control and training in regulated industry.
• Experience in document control within a GMP/compliance environment.
• Proven ability to manage multiple projects and priorities with strong organizational skills.

Responsabilidades

• Maintain Civica Petersburg Document Control System and act as site SME on document control.
• Manage Document Change Requests and Document Change Controls.
• Coordinate document control and training timelines.
• Oversee periodic review timeliness and training verification.
• Edit and review controlled documents to ensure regulatory compliance and internal procedures.
• Perform impact assessments for document changes and ensure traceability.

Conocimientos

Strong organization

Interpersonal & written communication

Software/electronic applications

Autonomy & self-motivation

Process improvement

Risk-based decision making

Educación

Bachelor’s degree

Regulated industry document control experience

Experience with SOPs writing

Herramientas

Veeva or EDMS

SOP writing

Descripción del empleo

Civica, Inc. seeks a skilled Quality Systems Associate – Document Control at its Petersburg, Virginia site.

You will ensure the document control system aligns with regulatory expectations, manage change controls, and support training and SQMS processes to keep quality medicines flowing to patients. The role emphasizes cGMP compliance, cross-functional collaboration, and continuous improvement in a fast-paced pharmaceutical setting.