Quality Systems Associate

About Civica
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.

Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. )

To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

)

Job Description
The Quality Systems Associate will join the Civica, Inc. ("Civica") organization and its team 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 fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

The role supports aspects of quality to ensure compliance with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices), internal standards, and expectations for the development and reliable supply of quality medicines. Responsibilities include supporting activities related to change control, investigations and CAPA, complaints, Quality Risk Management, inspection readiness, metrics and other quality systems activities as needed.

Essential Duties And Responsibilities

• Work cross functionally to participate in the implementation and maintenance of the site's quality system framework including quality systems and processes necessary to enable the development and reliable supply of Civica generic medications to patients.
• Support, track, and trend quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, product quality complaints, Annual Product Quality Review (APQR), and management notification.
• Support cGMP compliance and inspection readiness within the organization.
• Participate in internal self-assessment audits.
• Participate in root cause analysis investigations as either investigator or Quality Assurance.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Working across functions to ensure compliant document control and training programs.
• Contribute to Quality Risk Management and Data Governance Processes as needed.
• Participate in activities to support regulatory agency inspections.
• Support site objectives with a minimal amount of supervision. Includes simple project management that may involve other functional areas.
• Promote a quality mindset and quality excellence approach to all activities.
• Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.

Basic Qualifications And Capabilities

• 4+ years' experience working directly with manufacturing in the pharmaceutical or medical device industries. Appropriate combinations of experience and bachelor-level or higher education.
• Participating in activities that support regulatory agency inspections is required.
• 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.
• Project management, organization, and execution skills are desired.
• Ability to apply technical expertise to solve problems and issues.
• 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.

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.