Pharmaceutical Quality Assurance Specialist: MODA Environmental Monitoring System Administrator

6 days ago

Petersburg, United States Civica Rx Full time

About Civica Rx

Civica Rx is a pioneering social welfare organization dedicated to addressing chronic generic drug shortages and high prices in the United States. The organization was founded in 2018 by health systems and philanthropies to ensure quality generic medications are accessible and affordable to everyone. Civica Rx is led by a team of experienced healthcare and pharmaceutical industry leaders.

With over 55 health systems on board, representing more than 1,500 hospitals and one-third of all U.S. hospital beds, Civica Rx has made significant strides in its mission. The organization has also begun supplying the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile with essential medicines.

Civica Rx recently announced plans to expand its mission through CivicaScript, a unit aimed at the outpatient pharmacy space. This ambitious goal involves manufacturing and distributing insulins that will be available to people with diabetes at significantly lower prices than those currently on the market. Starting in 2024, Civica Rx's affordable insulins will benefit individuals with diabetes who have been forced to choose between life-sustaining medicines and living expenses, particularly those uninsured or underinsured.

The Civica Rx team is guided by a single policy: 'Do What Is in the Best Interest of Patients.' The organization's manufacturing facility in Petersburg, Virginia, is set to become the future home of affordable insulin and essential sterile injectable medicines. The facility, currently in late-stage construction, will require skilled professionals to join its team.

This role offers an exceptional opportunity to be part of a cutting-edge team that is redefining the pharmaceutical industry. As a Quality Assurance Specialist II - MODA Environmental Monitoring System Administrator, you will play a crucial role in ensuring the implementation, management, and ongoing maintenance of the MODA system. Your primary responsibilities will include managing the MODA Environmental Monitoring (EM) System, creating and maintaining user accounts, building and managing static data, and ensuring the system conforms to regulatory requirements.

The ideal candidate will possess a Bachelor's Degree in a related field, plus 6+ years of Quality Control MODA Environmental Monitoring Administrator experience. Proven experience in leading and deploying an environmental monitoring system is essential, as is knowledge of Quality Assurance/Quality Control Operations. The successful candidate will also have experience with system design and development, starting from business requirements analysis through implementation and support.

Key Responsibilities:

  • Manage and maintain the MODA Environmental Monitoring (EM) System.
  • Create and maintain user accounts.
  • Build and manage static data.
  • Support the entry of data.
  • Develop and implement ongoing training.
  • Ensure controls related to approval levels and user access are established and maintained.
  • Manage user inquiries for troubleshooting and resolve issues.
  • Proactively identify and work to resolve project and system issues.
  • Ensure MODA conforms to regulatory requirements.
  • Oversee and participate in the development of application documentation.
  • Work in coordination with business stakeholders to develop and prepare reports, metrics, and dashboards.
  • Work closely with various business stakeholders to lead and manage business requirements and system solution delivery.
  • Manage ongoing maintenance and enhancements (i.e. new releases). Drive improvements and efficiencies.
  • Support adding vault capabilities as identified by the business.

Basic Qualifications and Capabilities:

  • Bachelor's Degree in a related field plus 6+ years of Quality Control MODA Environmental Monitoring Administrator experience, or equivalent work experience.
  • Proven experience in leading and deploying an environmental monitoring system.
  • Experience in a pharmaceutical or any highly regulated environment.
  • Knowledge of Quality Assurance/Quality Control Operations.
  • Experience with system design and development starting from business requirements analysis through implementation and support.
  • Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
  • Ability to work autonomously and within established guidelines, procedures, and practices.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
  • Excellent interpersonal and written communication skills and experience using various software/electronic applications.

Estimated Salary: $80,000 - $110,000 per year, based on location and experience.

Location: Petersburg, VA - 23803

Job Type: Full-time

Shift: Day Shift, Monday through Friday

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