Quality Systems Associate
1 week 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, particularly for those who need them most.
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.
Position OverviewThe Quality Systems Associate - Document Control Specialist will play a critical role in ensuring the quality and compliance of our document control system at our Petersburg, Virginia site. This individual will be responsible for maintaining our Document Control System, executing applicable program activities, and serving as the site's subject matter expert on document control.
Key Responsibilities- Document Control System Maintenance: Ensure the consistent application of Civica Rx and regulatory expectations to documents and manage applicable repositories.
- Document Change Control: Manage the document change control process, including impact assessments, training verification, and true copy verification.
- Training and Development: Coordinate and perform training activities, including training verification and document control system training.
- Quality System Support: Support overall quality system programs, including training, supplier quality, change control, and deviation/CAPA systems.
- cGMP Compliance: Support cGMP compliance and inspection readiness within the organization.
- Quality Culture Development: Foster the development of a quality culture within the cGMP environment.
- Education and Experience: 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.
- Skills and Abilities: Strong organization and execution skills, excellent interpersonal and written communication skills, and experience using various software/electronic applications.
- Personal Qualities: Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
Civica Rx offers a dynamic and collaborative work environment, with opportunities for professional growth and development. We are committed to delivering high-quality results and making a meaningful impact on the lives of patients and families affected by generic drug shortages.
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Quality Systems Associate
1 week ago
Washington, Washington, D.C., United States Civica Rx Full timeAbout Civica RxCivica 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 medications for patients in need.We are a collaborative effort between health systems and philanthropies, with a team of...
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