Document Control and Training Administrator
Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica’s mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.
Because the United States experiences chronic shortages of essential generic medicines used daily in hospitals, we are building a state-of-the-art sterile injectable manufacturing facility to combat these shortages. This new facility is part of our broad strategy to stabilize the supply of generic medicines for emergency rooms, surgeries, COVID-19 patient care, and an array of other serious conditions.
WHO CIVICA SERVES
While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and “340B” hospitals caring for vulnerable patients in some of the country’s most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile.
With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs under contract by 2023.
As we continue to grow, we have many exciting opportunities for multiple types of roles and with opportunity to progress YOUR career.
To find out more about how Civica’s innovative model is directly impacting patient care, click here to read a recent article from the New England Journal of Medicine.
Intro to Civica
The Document Control and Training Administrator will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’s new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. Responsibilities of the position include ensuring documents are maintained and controlled, managing the document change control process and aid other personnel in utilizing the document control system, as well as updating and maintaining personnel training curricula within the training management system.
The role is essential to assure the Petersburg site’s document control system complies with applicable regulatory standards (e.g., Current Good Manufacturing Practices) and expectations for the development and reliable supply of quality medicines.
Essential Duties and Responsibilities:
- Oversight of the Document Management System
- Management of Document Change Controls
- Aiding personnel in utilizing the electronic Document Management System
- Ensuring all GMP documentation is maintained and controlled per company policies and procedures
- Author procedural documents related to area of responsibility
- Review document and document change controls from across the site
- Monitor, track, and trend document management systems data
- Issuance, tracking and reconciliation of batch records
- Develop, assign, and maintain personnel training curricula within the Training Management System
- Monitor, track, and trend training metrics for site personnel
- Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions
- Other document control and training management related duties as required
Basic Qualifications and Capabilities:
Bachelor’s degree with a minimum of 3 years document control and training administration experience within regulated industry.
Strong organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
Supporting regulatory agency inspections will be required.
Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
Ability to work autonomously and within established guidelines, procedures, and practices.
Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.
Continuously looking for opportunities to learn, build skills and share knowledge with others.
Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
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.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.
The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.
You must be eligible to work in the US to be considered an applicant.