Quality Specialist II - MODA Administrator (397)
- Employer
- Civica Rx
- Location
- Petersburg, VA
- Start date
- Jan 19, 2025
View more categoriesView less categories
- Discipline
- Clinical, Clinical Medicine, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital, Best Places to Work
Job Details
About Civica:
Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.
Shortages put patients at risk and waste hospital resources.
Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied 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 currently supplies medicines to health system members in 49 states.
Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.
Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.
The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.
Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.
Join us. Learn more at www.civicarx.org
Job Description:
MODA Administrator, Microbiology will join the Civica, Inc. (“Civica”) organization and its newly created team at the Petersburg, Virginia site by bringing their knowledge and experience in patient service 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. MODA is a best-in-class environmental monitoring and microbiology data management system. Candidates with experience with software such as LabWare LIMS will also be considered for the role.
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 scientific field plus 6+ years of Quality Control MODA Environmental Monitoring Administrator experience or equivalent work experience with a LIMS system 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, from business requirements analysis to implementation and support.
- 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.
- 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.
Preferred Qualifications:
- Work history in a pharmaceutical microbiology laboratory.
- 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
Physical Demands and Work Environment:
The physical demands described here represent those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodation 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 is frequently required to use hands or fingers and 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 40 pounds. The noise level in the work environment is usually low to moderate.
The company is an equal opportunity employer, a drug-free workplace, and complies with ADA regulations as applicable.
Company
WHY CIVICA?
Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica’s mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.
WHO CIVICA SERVES
While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and “340B” hospitals caring for vulnerable patients in some of the country’s most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile. With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs available by 2023.
- Website
- https://civicarx.org/
- Location
-
1 Civica Way
Petersburg
VA
23805
United States
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