Quality Systems Associate

Overview

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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, representing over 1,500 hospitals and one-third of all U.S. hospital beds.

Civica has begun to supply the U.S. Department of Veterans Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines. Civica plans to expand its mission via CivicaScript into the outpatient pharmacy space and to manufacture and distribute insulins at significantly lower prices. Civica’s mission is to ensure quality generic medications are accessible and affordable to everyone.

The Civica manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines and is currently in late-stage construction.

The Quality Systems Associate will join Civica, Inc. ("Civica") at the Petersburg, Virginia site, bringing 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.

• 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.
• Work 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 minimal 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.

• 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.
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