Quality Systems Associate
4 weeks ago
Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."
Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.
More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.
Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.
Learn more about Civica's plans and progress at
Job Description:
The Quality Systems Specialist - Change 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 the manufacture and supply of essential generic sterile injectable medications.
Responsibilities of the position include but are not limited to oversight of the quality management system (QMS) change control program.
The role is essential to ensure the Petersburg site's Change Control Program complies with applicable regulatory standards (e.g., Current Good Manufacturing Practices) and expectations for the development and reliable supply of quality medicines. and reliable supply of quality medicines.
Essential Duties and Responsibilities:
- Responsible for the Quality Management System oversight and execution of the Change Control 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.
- Facilitate, monitor, and drive change control on-time completion.
- Support overall quality system programs as needed to include but not limited to document control, supplier quality, and investigation systems.
- Track, trend, and analyze QMS change control metrics for the site.
- Developing collaborative relationships with end users and providing guidance on standard processes in Change Control.
- Act as the site's subject matter expert on changed 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.
- Support cGMP compliance and inspection readiness within the organization.
- Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
- Fosters 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.
- Bachelor's degree with a minimum of 4+ years of document control experience within a regulated industry or a combination of equivalent education and experience.
- Led a cGMP Change Control program.
- Strong organization, and execution skills with an attention to detail.
- Ability to successfully manage multiple 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 opportunities to learn, build skills, and share knowledge with others.
- Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
- Interact with other functions and be able to take ownership of and follow through on assigned projects.
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