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Quality Systems Associate
2 months ago
Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure the consistent availability of affordable medicines for patients in need.
We are a collaborative effort between health systems and philanthropies, with a team of experienced healthcare and pharmaceutical industry leaders at the helm. Our goal is to make a meaningful impact on the lives of patients and families affected by generic drug shortages.
Quality Systems Associate - Document ControlWe are seeking a highly skilled Quality Systems Associate - Document Control to join our team at our Petersburg, Virginia site. As a key member of our quality team, you will be responsible for ensuring the consistent application of Civica and regulatory expectations to documents and the management of applicable repositories.
Your primary focus will be on maintaining our Document Control System, executing applicable program activities, and acting as the site's subject matter expert on document control. You will also be responsible for authoring procedural documents, interpreting compliance and regulatory requirements, and tracking, trending, and analyzing Document Control System metrics.
As a Quality Systems Associate - Document Control, you will have the opportunity to work collaboratively with end users, provide guidance on standard processes, and support overall quality system programs. You will also be responsible for fostering a quality culture within our cGMP environment and promoting a safety and quality mindset.
Responsibilities- Maintain Civica Petersburg's Document Control System and execute applicable program activities.
- Act as the site's subject matter expert on document control.
- Author procedural documents related to area of responsibility.
- Interpret compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation.
- Track, trend, and analyze Document Control System metrics for the site.
- Develop collaborative relationships with end users and provide guidance on standard processes in document control.
- Support overall quality system programs as needed.
- Foster a quality culture within the cGMP environment.
- Bachelor's degree with a minimum of 2 years 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.
