Quality Specialist II
3 months ago
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. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)
Job Description:
The Quality Specialist II - MODA Environmental Monitoring System Administrator will join the Civica, Inc. ("Civica") organization and its newly forming 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 new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
The MODA System Administrator is responsible for the implementation, management, and ongoing maintenance of the MODA system used at Civica.
Essential Duties and Responsibilities:
- Manages MODA Environmental Monitoring (EM) System.
- Creates and Maintains User Accounts.
- Builds and manages static data.
- Supports manages and entry of data.
- Develops and implements ongoing training.
- Ensures controls related to approval levels and user access are established and maintained.
- Manages user inquiries for troubleshooting and resolves issues.
- Proactively identifies and works to resolve project and system issues.
- Ensures MODA conforms to regulatory requirements.
- Oversees and participates in the development of application documentation.
- Works in coordination with business stakeholders to develop and prepare reports, metrics, and dashboards.
- Works closely with various business stakeholders to lead and manage business requirements and system solution delivery.
- Manages ongoing maintenance and enhancements (i.e. new releases)
- Drive improvements and efficiencies.
- Supports 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 is required.
- 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 required.
Preferred Qualifications:
- Strong knowledge of computerized system validation
- Experience with ELN and implementation of paperless lab.
- A strong knowledge of the computerized system principles, standards, and regulations, such as GAMP 5, 21 CFR Part 11, EU Annex 11, etc.
Position ID: 397
Shift: Day Shift. Monday through Friday.
PandoLogic. Keywords: Quality Control / Quality Assurance Specialist, Location: Petersburg, VA - 23803 , PL: 594917026-
Quality Systems Specialist II
3 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...
-
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.The organization was established in 2018 by health systems and philanthropies, with an experienced team of healthcare and pharmaceutical industry leaders at the helm.Today, more than 55 health...
-
Quality Assurance Specialist
3 days ago
Petersburg, United States Civica Rx Full timeAbout the RoleCivica Rx is seeking a highly skilled Quality Assurance Specialist to join our team at our Petersburg, Virginia site. As a Quality Assurance Specialist, you will be responsible for maintaining quality systems and oversight to ensure the validation/qualification and operation of process, facility, equipment, and computer systems meet cGMP and...
-
Quality Specialist
2 weeks ago
Petersburg, United States Phlow Corp Full timeDescriptionThe Pharmaceutical Quality Specialist is responsible for overseeing and managing documentation and processes essential for qualification activities related to pharmaceutical manufacturing and quality processes. This role ensures compliance with regulatory standards (e.g., FDA, EMA, and cGMP) and company policies, ensuring that all quality system...
-
Quality Assurance Specialist
1 week ago
Petersburg, United States Actalent Full timeJob Title: Quality Assurance SpecialistAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team in South Chesterfield, VA. As a key member of our production team, you will be responsible for ensuring the quality and safety of our products.Key ResponsibilitiesPerform all testing of raw materials and finished products to...
-
Procurement Specialist II
4 days ago
Saint Petersburg, United States General Dynamics Ordnance And Tactical Systems Full timeOverviewGeneral Dynamics Ordnance and Tactical Systems (GD-OTS), a premier provider of ordnance weapons and tactical systems to the U.S. Department of Defense and allied nations, has an opening for an onsite Procurement Specialist II to join our St. Petersburg, FL Team. We take pride in supporting the mission of the warfighter by delivering the best, to the...
-
QA Compliance Specialist II
4 days 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...
-
QC Specialist II Insulin
2 months 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...
-
Manufacturing Technician II
2 days ago
Petersburg, United States Dover Corporation Full timeYour Role as Assembler IIAs an Assembler II, you will be responsible for operating and troubleshooting automated machinery in the production of sheet metal refrigerated cases. Your primary objective will be to ensure seamless assembly processes, identifying and addressing any issues promptly.You will work closely with our production team to maintain...
-
Quality Systems Specialist
7 days ago
Petersburg, United States BioSpace, Inc. Full timeAbout the RoleWe are seeking a Quality Systems Specialist to join our team at BioSpace, Inc. The ideal candidate will have experience in quality assurance and regulatory affairs.About UsBioSpace, Inc. is a leading provider of pharmaceutical services and solutions.ResponsibilitiesDevelop and implement quality systems and processes to ensure compliance with...
-
Pharmaceutical Quality Assurance Engineer
2 weeks ago
Petersburg, United States BioSpace, Inc. Full timeAbout This OpportunityWe are seeking a skilled Quality Assurance Engineer II to join our team at BioSpace, Inc. in Petersburg, Virginia.This is an exciting opportunity to contribute to the development and implementation of quality systems and processes that ensure the manufacture and supply of essential generic sterile injectable medications.The Quality...
-
Pharmaceutical Quality Assurance Specialist
3 weeks ago
Petersburg, Virginia, United States Civica Rx Full timeCivica Rx is a leading social welfare organization dedicated to reducing generic drug shortages and related high prices in the United States.As a QA Operations Specialist, you will join our team at the Petersburg, Virginia site and contribute to the manufacture and supply of essential generic sterile injectable medications.This role is critical in ensuring...
-
QA Operations Specialist II
3 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...
-
Senior Quality Assurance Specialist
1 week ago
Petersburg, United States Civica Rx Full timeAbout this RoleCivica Rx is seeking an experienced Senior Quality Assurance Specialist to support quality systems and oversight for product process validation, cleaning validation, Quality Risk Management, and quality laboratory systems that meet cGMP and Civica compliance requirements.Key ResponsibilitiesWork with validation and engineering teams to provide...
-
Quality Assurance and Validation Specialist
3 weeks ago
Petersburg, United States Civica Rx Full timeCivica 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 advocate for patient-centric healthcare, Civica Rx aims to ensure that essential medications are accessible and affordable for everyone. Our team of experienced health care and pharmaceutical...
-
Petersburg, United States Civica Rx Full timeAbout Civica RxCivica Rx is a mission-driven organization established to reduce chronic generic drug shortages and related high prices in the United States. With over 55 health systems on board, representing over 1,500 hospitals and 30% of U.S. hospital beds, we've made significant strides in addressing this critical issue.In our relentless pursuit of...
-
Software Quality Assurance Specialist
1 week ago
Petersburg, United States BioSpace, Inc. Full timeJob DetailsCivica is a 501(c)(4) social welfare organization established to reduce chronic generic drug shortages in the US. We work with health systems and philanthropies to address this issue.We are seeking a highly skilled Software Quality Assurance Specialist who can help us achieve our mission.The estimated salary for this position is around $120,000...
-
Quality Assurance Engineer II
3 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...
-
Quality Assurance Engineer II
3 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...
-
Petersburg, United States BioSpace, Inc. Full timeAbout the RoleCivica, Inc. is a leading social welfare organization established in 2018 to reduce chronic generic drug shortages and related high prices in the United States.We are seeking a highly skilled Sterile Pharmaceutical Quality Assurance Specialist to join our quality organization at our Petersburg, Virginia site. This individual will play a...
