Quality Systems Associate - Document Control (391)

Civica Rx • Petersburg, VA

7d • Onsite

About The Position

The Quality Systems Associate - Document Control joins Civica, Inc. at its Petersburg, Virginia site, a fill-finish facility manufacturing and supplying essential generic sterile injectable medications. The position maintains the site’s Document Control System and supports compliance with applicable regulatory standards, including current Good Manufacturing Practices (cGMP). The associate serves as the site subject matter expert for document control, supports reliable supply of quality medicines, and helps personnel use the document control system.

Requirements

• Bachelor’s degree and at least 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 track record of managing multiple projects and priorities.
• Excellent interpersonal and written communication skills, and experience using various software and electronic applications.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
• Ability to work autonomously within established guidelines, procedures, and practices.
• Commitment to delivering high-quality results, collaborating to overcome challenges, and focusing on priorities.
• A continuous improvement mindset.
• Ability to identify problems proactively and work collaboratively on risk-based, compliant solutions.
• Previous document control and training administration experience in the pharmaceutical industry.
• Previous experience with Veeva or another electronic document and training management system.
• Previous experience writing and/or revising Standard Operating Procedures.

Responsibilities

• Maintain the Petersburg Document Control System and execute applicable program activities 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.
• Build 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 a Quality Culture in the cGMP environment and promote a safety- and quality-minded approach to activities.

Benefits

• Reasonable accommodations may be made to enable individuals with disabilities to perform the position’s functions.

What This Job Offers

• Job Type: Full-time