Quality Systems & Document Control Specialist

BioSpace; Petersburg (VA); On-site; USD 70,000 - 90,000; Full time

Job summary

Civica, Inc. in Petersburg, Virginia, is seeking a Quality Systems Associate for Document Control to ensure regulatory-aligned documentation and robust control processes.

You will serve as the site SME for document control, manage change controls, and coordinate training to maintain cGMP compliance at Civica’s fill-finish facility. Responsibilities include updating procedures, performing impact assessments, and ensuring timely periodic reviews while supporting broader quality system programs.

Qualifications

• Bachelor's degree in a related field or extensive experience in document control within a regulated industry.
• Strong organizational and execution skills with a track record of managing multiple projects and priorities.
• Excellent interpersonal and written communication skills; proficient with various software/electronic applications.

Responsibilities

• 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 Timelines and adherence to regulatory requirements.
• Edit and review controlled documents to ensure compliance with internal procedures and external regulations.
• Perform impact assessments for Document Change Controls and training verification.
• Verify true copies and ensure GMP documentation is controlled and reconciled.
• Author procedural documents related to area of responsibility.

Skills

Document control

Regulatory compliance

Veeva

SOP writing

Training administration

GMP knowledge

Project management

Communication skills

Education

Bachelor's degree

Tools

Veeva

EDMS

Job description

Civica, Inc. in Petersburg, Virginia, is seeking a Quality Systems Associate for Document Control to ensure regulatory-aligned documentation and robust control processes.

You will serve as the site SME for document control, manage change controls, and coordinate training to maintain cGMP compliance at Civica’s fill-finish facility. Responsibilities include updating procedures, performing impact assessments, and ensuring timely periodic reviews while supporting broader quality system programs.