Quality Systems Associate
1 day 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. Founded in 2018 by health systems and philanthropies, Civica Rx aims to ensure the consistent availability of affordable medications.
With over 55 health systems and 1,500 hospitals on board, Civica Rx has made significant strides in addressing the issue of generic drug shortages. The organization has also supplied essential medicines to the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile.
Job Description:Quality Systems AssociateThe Quality Systems Associate will play a crucial role in ensuring the Petersburg site's Change Management Program complies with regulatory standards and expectations for the development and reliable supply of quality medicines.
Responsibilities include:
- Oversight of the quality management system (QMS) change management program
- Reviewing, editing, and approving change control documentation to ensure compliance with quality, regulatory, and SOP requirements
- Scheduling and facilitating cross-functional change control meetings and providing guidance and consultation to change control owners
- Facilitating, monitoring, and driving change control on-time completion
- Supporting overall quality system programs, including document control, supplier, and investigation systems
- Tracking, trending, and analyzing QMS information for the site
- Developing collaborative relationships with end users and providing guidance on standard processes in Change Control
- Acting as the site's subject matter expert on change control
- Partnering with members of the Quality Assurance team and/or end users of the system to promote continuous improvements to the Change Control system, process, and associated procedures
- Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation
- Supporting cGMP compliance and inspection readiness within the organization
- Proactively identifying and working collaboratively to resolve problems by taking risk-based and compliant approaches to solutions
- Fostering the development of a Quality Culture within the cGMP environment
- Practicing and promoting a safety and quality mindset and quality excellence approach to all activities
Basic Qualifications and Capabilities:
- Bachelor's degree with a minimum of 3 years document control experience within a regulated industry or a combination of equivalent education and experience
- Managed or participated in a cGMP Change Management program
- Strong organization, and execution skills with an attention to detail
- Ability to successfully manage multiple priorities
- Excellent interpersonal and written communication skills
- Experience with Electronic Documentation Management Systems
- 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 identifying and working collaboratively to resolve problems by taking risk-based and compliant approaches to solutions
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