Quality Assurance Packaging Supervisor
Company: Civica Rx
Location: Petersburg
Posted on: January 26, 2023
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Job Description:
About Civica
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
industry leaders.
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
medications.
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
well-underway.
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. (
https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189 )
To learn more about Civica's plans to bring affordable insulin to
Americans living with diabetes, click - here -to read an article in
BioSpace.
(
https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/
)
Job Description
The Quality Assurance - Packaging Supervisor 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, shop floor
oversight and the generation, review and/or approval of policies,
procedures, reports, batch records 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 packaging operations to enable reliable supply
of quality generic medications to patients.
Promote a quality mindset and quality excellence approach to all
activities.
Promote a safety mindset and focus on safety for all operations
activities.
Responsible for operational compliance aspects of packaging of
products including but not limited to -automated and manual product
inspection, packaging batch record review, batch disposition, and
shop-floor quality.
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
requirements.
Establish and maintain Standard Operating Procedures and training
for artwork component controls and handling.
Establish and maintain Standard Operating Procedures and training -
-consistent with cGMPs for QA shop-floor support.
Provide leadership, direction, and support to ensure shop floor
associates and operators are qualified, achieve a high level of
competence, are motivated and carry out their duties in a safe
manner.
Maintain written procedures and associated records for personnel
qualification and training and support the delivery of compliance
training sessions.
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, from development and/or other manufacturing
sites.
Establish and maintain Standard Operating Procedures, and training
to ensure packaging and artwork components are qualified and their
suppliers are approved in accordance with Civica and GMP
requirements.
Establish and maintain Standard Operating Procedures, and training
to ensure that all components, packaging material, labelling and
drug products are released in accordance with the registered
specifications.
Responsible for Quality shop-floor oversight including real-time
batch record review, response to deviations and implementation of
corrective actions.
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 solutions.
Travel limited but may occasionally be required.
Basic Qualifications and Capabilities:
Bachelor's degree in a scientific discipline with a minimum of 5
years Quality/CGMP experience in the pharmaceutical industry or
equivalent experience at the discretion of the hiring manager.
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.
Participation and leading activities to support regulatory agency
inspections required.
Prior experience in a supervisory role highly desired.
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.
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 desirable.
Experience in Drug Enforcement Agency requirements for the handling
and distribution of controlled substances is desired.
Prior experience in a supervisory role highly desired.
PI201562036
Keywords: Civica Rx, Richmond , Quality Assurance Packaging Supervisor, Other , Petersburg, Virginia
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