Document Control & Quality Systems Specialist

Civica Rx

Petersburg (VA)

On-site

USD 65,000 - 90,000

Full time

3 days ago
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Job summary

Civica Petersburg, VA seeks a Quality Systems Associate - Document Control to ensure the site’s document control system complies with GMP and regulatory expectations. You will manage document change processes and support other quality system activities to uphold patient safety.

Responsibilities include training coordination, true copy verification, and maintaining controlled documents, aligning with the site’s regulatory standards and internal procedures.

Qualifications

  • Bachelor’s degree with relevant experience or equivalent.
  • Experience in document control within a regulated industry.
  • Strong written and verbal communication abilities.
  • Ability to work autonomously in a fast-paced environment.
  • Proven track record of managing multiple projects and priorities.
  • Experience with GMP and regulatory expectations.

Responsibilities

  • Maintain Civica Petersburg’s Document Control System and serve as SME on document control.
  • Manage Document Change Requests and Document Change Controls.
  • Coordinate document control and training timelines.
  • Oversee Periodic Review Timeliness.
  • Edit and review controlled documents for regulatory compliance.
  • Perform Impact Assessments for Document Change Controls.
  • Coordinate training verification and true copy verification.
  • Ensure GMP documentation is maintained and controlled per policies.

Skills

Organizational skills
Communication skills
Self-motivated
Autonomous work
Process improvement
Problem solving
Pharma doc control
Veeva experience
SOP writing

Education

Bachelor’s degree

Tools

Veeva

Job description

Civica Petersburg, VA seeks a Quality Systems Associate - Document Control to ensure the site’s document control system complies with GMP and regulatory expectations. You will manage document change processes and support other quality system activities to uphold patient safety.

Responsibilities include training coordination, true copy verification, and maintaining controlled documents, aligning with the site’s regulatory standards and internal procedures.

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