Job Description:

The Quality Systems Associate - Document Control will join the Civica, Inc. (“Civica”) organization 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 manufacturing and supplying essential generic sterile injectable medications.  Responsibilities of the position include ensuring consistent application of Civica and regulatory expectations to documents and the management of applicable repositories, managing the document change control process, and aiding other personnel in utilizing the document control system.

The role is essential to ensure 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:

·       Responsible for maintenance of Civica Petersburg’s Document Control System and execution of applicable program activities, acting as the site’s subject matter expert on document control.

o   Facilitates document establishment and revision through management of Document Change Requests and Document Change Controls.

o   Coordinates document control and training timelines.

o   Oversees Periodic Review Timeliness

o   Participation in the editing and reviewing of controlled documents, ensuring adherence to applicable internal procedural and external regulatory requirements.

o   Performs Impact Assessments for Document Change Controls.

o   Coordinates and performs training verification

o   Performs True Copy verification

o   Ensures all GMP documentation is maintained and controlled per company policies and procedures, including issuance and reconciliation of controlled copies.

·       Authors procedural documents related to area of responsibility.

·       Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation.

·       Track, trend, and analyze Document Control System metrics for the site.

·       Developing collaborative relationships with end users and providing guidance on standard processes in document control.

·       Support overall quality system programs as needed to include, but not be limited to, training, supplier quality, change control, and deviation/CAPA systems.

·       Support cGMP compliance and inspection readiness within the organization.

·       Foster the development of a Quality Culture within the cGMP environment.

·       Practice and promote a safety and quality mindset and quality excellence approach to all activities.

Basic Qualifications and Capabilities:

·       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 successfully managing multiple projects and priorities.

·       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 process improvement opportunities.

·       Proactively identify and work collaboratively to resolve problems by 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, a drug-free workplace, and complies with ADA regulations as applicable.