Quality Specialist II
3 months ago
About 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 injectable medications, manufacturing challenges and predatory pricing are both the causes and results.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) 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. They represent over 1,500 hospitals and over 30 percent 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 of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”
Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.
More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.
Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.
Learn more about Civica’s plans and progress at www.civicarx.org
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.
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