Company: Civica Rx
Posted on: January 26, 2023
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
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
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
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. (
To learn more about Civica's plans to bring affordable insulin to
Americans living with diabetes, click here to read an article in
The Associate Microbiologist 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. Responsibilities of the position
include supporting the establishment and maintenance the
microbiology testing laboratory from onset of building the
laboratory and initial qualification of equipment.
The role is essential to assure the Petersburg site's microbiology
laboratory and testing comply with applicable regulatory standards
(e.g., Current Good Manufacturing Practices, and FDA Guidance
documents) and expectations for the development and reliable supply
of quality medicines.
Responsibilities also include, but are not limited to, the
generation and/or review of procedures, reports, and other records
necessary to support the design, implementation, and maintenance of
a microbiology laboratory that meets or exceeds FDA
Essential Duties and Responsibilities:
Support the establishment and maintenance of the microbiological
testing laboratory to ensure compliance with cGMPs and industry
standards for best practices.
Perform microbiological testing methods consistent with USP testing
requirements. Including but not limited to the following
microbiological testing and procedures: bioburden, bacterial
endotoxin, identification of microbial isolates and objectional
organisms, viable/non-viable particulate monitoring, and growth
promotion studies. Conduct and maintain qualifications of
laboratory equipment as well as ongoing maintenance and
Establish and coordinate test sampling plans.
Perform microbiological testing and sample collection to support
environmental monitoring (EM) and utilities systems.
Participate in verification of microbiological methods and method
transfers. Participate in the development of training programs for
Lead and/or participate in investigations related to laboratory
operations and non-conforming results. Identify, track, and
facilitate resolution of technical issues.
Conduct quality risk assessments related to microbiology and
environmental monitoring. Proactively identify and work
collaboratively to resolve problems taking risk-based and compliant
approaches to solutions.
Author and/or review SOPs, protocols, reports, test method and
product specification documents as applicable. Promote a quality
mindset and quality excellence approach to all activities. Travel
(up to 10%) may be required.
Basic Qualifications and Capabilities:
Bachelor's degree in a scientific discipline (microbiology degree
preferred) with a minimum of 3 years Quality/cGMP experience in the
pharmaceutical industry. Strong project management, organization,
and execution skills.
Microbiology testing and environmental monitoring experience.
Participation in activities to support regulatory agency
Excellent interpersonal and written communication skills and
experience using various software/electronic applications
Self-motivated, flexible, and able to work in a small, fast-paced,
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. Continuously
looking for opportunities to learn, build skills and share
knowledge with others.
Experience in sterile injectable manufacturing, aseptic processing,
and facility qualification.
Experience with the following microbiological testing and
procedures: Sterility testing and method suitability testing per
USP Acceptance testing and use of biological indicators
Keywords: Civica Rx, Richmond , Associate Microbiologist, Other , Petersburg, Virginia
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