Quality Systems Associate - Document Control (391)

Civica Rx • Petersburg, VA

6d • Onsite

About The Position

The Quality Systems Associate - Document Control will join Civica, Inc. at its Petersburg, Virginia site, a fill-finish facility dedicated to manufacturing and supplying essential generic sterile injectable medications. The role maintains the site’s Document Control System and helps ensure that documentation and related processes meet company policies and applicable regulatory expectations, including current Good Manufacturing Practices (cGMP). The associate serves as the site subject matter expert for document control, supports users of the system, and contributes to quality-system programs and inspection readiness.

Requirements

• 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.
• Strong organization and execution skills, with a proven track record of managing multiple projects and priorities.
• Excellent interpersonal and written communication skills.
• Experience using various software and electronic applications.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Previous document control and training administration experience within the pharmaceutical industry.
• Previous experience working with Veeva or other electronic document and training management systems.
• Previous experience writing and/or revising Standard Operating Procedures.
• Ability to speak or hear regularly and use hands or fingers to handle or feel objects, tools, or controls frequently.
• Ability to occasionally stand, walk, sit, reach with hands and arms, and lift and/or move up to 25 pounds.
• Close vision, distance vision, and the ability to adjust focus.

Nice To Haves

• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
• Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously seeks process-improvement opportunities.
• Proactively identifies and collaboratively resolves problems using risk-based and compliant approaches.

Responsibilities

• Maintain the Petersburg site’s Document Control System and execute applicable program activities, serving as the site subject matter expert on document control.
• Facilitate document establishment and revision by managing Document Change Requests and Document Change Controls.
• Coordinate document control and training timelines and oversee periodic review timeliness.
• Participate in editing and reviewing controlled documents to ensure compliance with internal procedures and external regulatory requirements.
• Perform impact assessments for Document Change Controls.
• Coordinate and perform training verification and true copy verification.
• Ensure GMP documentation is maintained and controlled according to company policies and procedures, including issuance and reconciliation of controlled copies.
• Author procedural documents related to the area of responsibility.
• Interpret compliance and regulatory requirements and incorporate them into departmental systems, procedures, and documentation.
• Track, trend, and analyze site Document Control System metrics.
• Develop collaborative relationships with end users and provide guidance on standard document control processes.
• Support quality-system programs as needed, including training, supplier quality, change control, and deviation/CAPA systems.
• Support cGMP compliance and inspection readiness.
• Foster the development of a Quality Culture in the cGMP environment.
• Practice and promote a safety and quality mindset and quality-excellence approach in all activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level