Quality Assurance Engineer II
5 days ago
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 Rx. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds.
Civica Rx 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.
The #1 Policy for the Civica Rx team has been "Do What Is in the Best Interest of Patients."
Civica Rx 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 Rx 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 Rx's plans and progress at
Job Description:
The Quality Assurance Engineer II will join the Civica Rx Quality organization 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 Rx's new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
Responsibilities:
Support quality systems and oversight to ensure the product process validation, cleaning validation, Quality Risk Management and quality laboratory systems meet cGMP and Civica Rx compliance requirements at the onset of building the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
Responsibilities also include, but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to provide quality oversight to ensure FDA requirements are met.
Essential Duties and Responsibilities:
Work with validation and engineering teams to provide Quality oversight for validation and qualification activities and ensure work is performed in a compliant and controlled manner.
Lead or participate in Quality Risk Management and analysis.
Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
Support and ensure compliance of product process transfers, including validation, from and/or to other manufacturing sites.
Lead activities related to product introduction to the site.
Support aseptic process simulations.
Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, laboratory control, Annual Product Quality Review (APQR), and management notification.
Provide quality review and support for laboratory method validation/verification and laboratory information management system (LIMS).
Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
Promote a quality mindset and quality excellence approach to all activities.
Promote a safety mindset and focus on safety for all operations activities.
Travel (up to 5%) may be required.
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