Quality Specialist II - MODA Administrator (397)
Civica

Job Info

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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:

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.

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