Quality Associate (Remote)
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 Associate will join the Civica, Inc. ("Civica") team in
supplying essential generic quality medicines to our hospital
members in the United States by bringing their knowledge and
experience to serve patients and pursue excellence in quality and
compliance.
The Quality Associate will provide the organization with quality
related support for improving and maintaining the Civica Quality
Management System (QMS) and ensure compliance to Food and Drug
Administration (FDA) regulations and current good manufacturing
practices (CGMPs). The Quality Associate's role will evolve to
support ongoing supply, product launches and product development
activities.
Essential Duties and Responsibilities:
Perform batch review and disposition of finished product records
for Private Label Distribution (PLD) and Civica contract
manufacturer finished drug products in accordance with product
specifications and SOPs
Support Veeva Electronic Document Management System (eDMS) as a
business administrator
Serve as Veeva Training administrator
Work with hiring managers to determine appropriate Learner Roles
and Training assignments
Maintain, update, route, and electronically store controlled
documents and metadata, as assigned
Drive improvements and efficiencies to the document workflow
process
Assist in the development and use of document templates
Assure controlled documents meet the defined standards
Maintain change control tracking log
Review/approve computerized systems validation protocols/summary
reports
Preparation of trend reports across Quality Systems, as needed
Assist with continuous improvement initiatives across all GMP
functions
Provide support during internal and external audits and
inspections
Supports QA Manager in qualification and approval of suppliers and
subcontractors
Develop working knowledge of applicable regulatory, corporate and
unit requirements
Promotes a quality mindset and quality excellence approach to all
activities
Communicate effectively with co-workers, management and clients
Additional duties as required to ensure appropriate quality
practices
Basic Qualifications and Capabilities:
Bachelor's degree in a scientific discipline, preferably in
biology, engineering or a similar field
A minimum of 3 years of working within the pharmaceutical or
medical device industry, in a CGMP environment
Promotes a quality mindset and quality excellence approach to all
activities
Quality Systems Experience in a CGMP environment
Ability to organize, understand, and present complex scientific and
technical information at a level that is appropriate for technical
and non-technical backgrounds
Attention to detail and analytical thinking
Excellent interpersonal and organizational skills
Excellent written/oral communication skills with a strong
discipline in Microsoft Programs is required
Self-motivated, flexible, and able to work in a small, fast-paced,
dynamic, environment
Ability to work autonomously within established guidelines,
procedures and practices
Committed to delivering high quality results, overcoming challenges
and focusing on what matters
Continuously looking for opportunities to learn, build skills and
share learning.
PI201562081
Keywords: Civica Rx, Richmond , Quality Associate (Remote), Other , Petersburg, Virginia
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