Quality Assurance Associate
Company: Civica Rx
Posted on: May 16, 2022
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. Approximately 200
medically necessary drugs are on the U.S. Food and Drug
Administration's shortage list. Manufacturing challenges and
predatory pricing are both the cause and result. Who suffers most?
Patients. 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. Led by an experienced team of health care and
pharmaceutical industry leaders. Today, more than 50 health systems
have joined Civica. They represent over 1,200 hospitals and over 30
percent 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 is improving patient outcomes and reducing
healthcare costs by making strides to ensure patients and their
needs come first and that essential generic medications are
accessible and affordable. Since established, the #1 Policy for the
Civica team has been "Do What Is in the Best Interest of Patients."
Civica is launching a subsidiary to enter the Outpatient pharmacy
market partnering with Blue Cross Blue Shield with the goal of
reducing drug prices, especially high-cost generic drugs where
market forces are not working to control drug costs. To find out
more about how Civica's innovative model is directly impacting
patient care, click here to read a recent article from the New
England Journal of Medicine. Watch this video to learn more about
Civica! Job Description: The Quality Assurance Associate 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 role is
essential to assure the Petersburg site's manufacturing and
operations activities comply with applicable regulatory standards
(e.g., Current Good Manufacturing Practices, Good Distribution
Practices) and expectations for the development and reliable supply
of quality medicines. Responsibilities of the position include
establishing and maintaining quality and compliance processes
associated with sterile manufacturing and operations from the onset
of building and qualifying 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, batch record
development and review, approval of policies, procedures, reports
and other records necessary to support the design, implementation,
and maintenance of manufacturing processes that meets or exceeds
FDA requirements. Essential Duties and Responsibilities:
- Working across functions, establish and maintain the site's
quality systems related to quality oversite of manufacturing
operations to enable reliable supply of quality generic medications
- Promote a quality mindset and quality excellence approach to
- Promote a safety mindset and focus on safety for all operations
- Support operational compliance aspects of sterile fill finish
manufacturing of products including but not limited to batch record
review and batch disposition,
- Ensure that all aspects of the handling, and manufacturing of
pharmaceutical products at the site comply with Civica and relevant
FDA and Drug Enforcement Administration (DEA) regulatory
- Support material and product disposition and quality control of
material and product within the Enterprise Resource Planning
- Support suppler and material qualification program and
establishment of a reduced testing program.
- Maintain current knowledge of FDA and Civica requirements to
keep pace with evolving requirements for manufacturing.
- Support, review and approve equipment qualifications and
product and process transfers, including validation, from
development and/or other manufacturing sites.
- Establish and maintain Standard Operating Procedures to ensure
that all components, raw materials, excipients, drug product
containers, closures, in-process materials, packaging material,
labelling and drug products are released in accordance with the
- Support quality processes and systems across the product
lifecycle including, but not limited to, change control, CAPA,
deviations and investigations, label control, laboratory control,
product quality complaints, Annual Product Quality Review (APQR),
and management notification.
- Participate in quality risk analysis.
- Proactively identify and work collaboratively to resolve
problems taking risk-based and compliant approaches to
- Travel limited but may occasionally be required. Basic
Qualifications and Capabilities:
- Bachelor's degree in a scientific discipline with a minimum of
3 years Quality/CGMP experience in the pharmaceutical industry.
Experience in sterile injectable manufacturing and packaging
operations is required.
- Strong project management, organization, and execution skills
with a proven track record of shop floor manufacturing.
- Quality assurance experience across the product development and
commercialization lifecycle including.
- Participation and leading activities to support regulatory
agency inspections required.
- 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, 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.
- Continuously looking for opportunities to learn, build skills
and share knowledge with others. Preferred Qualifications:
- Technical expertise in sterile pharmaceutical isolator
technology, combination product and medical devices is highly
- Experience in Drug Enforcement Agency requirements for the
handling and distribution of controlled substances is desired.
Keywords: Civica Rx, Richmond , Quality Assurance Associate, Other , Petersburg, Virginia
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