Pharmaceutical Quality Assurance Specialist: MODA Environmental Monitoring System Administrator
6 days ago
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
-
Quality Specialist II
4 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica RxCivica Rx 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. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.We are led by an experienced team of healthcare...
-
Quality Specialist II
1 month ago
Petersburg, United States Civica Rx Full timeAbout 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...
-
Quality Specialist II
4 weeks ago
Petersburg, United States Civica Rx Full timeAbout CivicaCivica is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and high prices in the United States. Our team of healthcare and pharmaceutical industry leaders is committed to ensuring quality generic medications are accessible and affordable to everyone.Job Description:Quality Specialist II - MODA...
-
Quality Assurance Specialist
2 weeks ago
Petersburg, United States BioSpace, Inc. Full timeAbout CivicaCivica 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.With a team of experienced health care and pharmaceutical industry leaders, Civica has expanded its mission beyond the hospital setting to include lowering...
-
Quality Assurance Specialist
4 weeks ago
St. Petersburg, United States West Pharmaceutical Services Full timeJob SummaryWe are seeking a skilled Quality Inspector to join our team at West Pharmaceutical Services. In this role, you will be responsible for performing inspections, testing, and releasing of in-process and finished goods materials, investigating issues concerning defects identified during production, and maintaining control of defective product or...
-
Quality Assurance Engineer
4 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica: 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...
-
Quality Assurance Specialist
7 days ago
Petersburg, United States Civica Rx Full timeAbout Civica Rx:Civica Rx 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.An experienced team of health care and pharmaceutical industry leaders leads the organization.Today, more than 55 health systems have joined Civica...
-
Quality Assurance Manager
2 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica RxCivica Rx 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. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.We are led by an experienced team of healthcare...
-
Quality Assurance Manager
7 days ago
Petersburg, United States Civica Rx Full timeJob Description:Civica Rx is seeking a Quality Assurance Manager to join our team at our Petersburg, Virginia site. As a Quality Assurance Manager, you will be responsible for leading the quality document control and training team and developing quality systems and processes to enable the manufacture of sterile injectable medications.Key Responsibilities:...
-
Quality Assurance Operations Supervisor
1 month ago
Petersburg, United States Civica Rx Full timeAbout 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...
-
Quality Assurance Manager
1 week ago
Petersburg, United States BioSpace, Inc. Full timeJob Title: Quality Assurance ManagerCivica, Inc. is seeking a Quality Assurance Manager to join our team at our Petersburg, Virginia site. As a Quality Assurance Manager, you will be responsible for leading the quality document control and training team and developing quality systems and processes to enable the manufacture of sterile injectable...
-
Director of Quality Assurance Leadership
2 weeks ago
Petersburg, Virginia, United States Sterling Life Sciences Full timeJob Summary Sterling Life Sciences is seeking a highly skilled Associate Director of Quality Assurance to lead the Quality Assurance Team. The ideal candidate will have a strong background in quality assurance management and a passion for driving excellence in the pharmaceutical industry. Key Responsibilities: 1. Review and approve quality system records,...
-
Quality Assurance Engineer
4 weeks ago
Petersburg, United States Civica Rx Full timeAbout CivicaCivica is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Established in 2018 by health systems and philanthropies, Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.With over 55 health systems on board, representing...
-
Quality Assurance Manager-GXP Computer Systems
2 months ago
Petersburg, United States Civica Rx Full timeAbout 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...
-
Computerized System Manager
2 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica RxCivica Rx 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. Our mission is to ensure that patients have access to affordable medications.Job DescriptionThe Computerized System Manager for Laboratory IT...
-
Quality Assurance Specialist
4 weeks ago
St. Petersburg, Florida, United States Compulink Cable Assemblies of Florida, INC Full timeJob Title: Quality Assurance SpecialistCompulink Cable Assemblies of Florida, INC is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, identifying and correcting potential problems, and driving quality improvement...
-
Quality Systems Specialist II for Data Integrity
2 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our team of experienced healthcare and pharmaceutical industry leaders is committed to ensuring quality generic medications are accessible and affordable to everyone.Job Description:The Quality...
-
Associate Director, Quality Assurance
2 weeks ago
Petersburg, United States Civica Rx Full timeAbout the RoleCivica Rx is seeking an experienced Associate Director, Quality Assurance to join our team at our Petersburg, Virginia site. As a key member of our quality assurance operations team, you will be responsible for establishing and maintaining quality systems and compliance oversight of manufacturing operations to ensure medications manufactured...
-
Quality Assurance Specialist
2 months ago
St. Petersburg, United States Plasma-Therm Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Plasma-Therm. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, and for implementing processes to improve our quality control systems.Key ResponsibilitiesQuality Inspection: Conduct thorough inspections...
-
Quality Assurance Engineer II
7 days ago
Petersburg, Virginia, United States Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. As a leading player in the pharmaceutical industry, Civica Rx is committed to ensuring the quality and accessibility of essential generic medications.The Quality Assurance Engineer II will play...