Training Development and Document Control Associate
Company: Civica Rx
Location: Petersburg
Posted on: January 26, 2023
|
|
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-/
)
Intro to Civica
https://vimeo.com/646267406
Position Summary
The Training Development and Document Control 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 and biosimilar insulin sterile injectable
medications.
Responsibilities of the position include establishing and
maintaining quality and compliance processes associated with
training and development to ensure requirements for Good
Manufacturing Practices (GMPs), are being met 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 ensuring
documents are maintained and controlled, managing the document
change control process and aid other personnel in utilizing the
document control system.
Essential Duties and Responsibilities
Design, develop and coordinate training program needs.
Develop and/or review and maintain site curriculums and training
requirements in the Veeva Electronic Learning Management System
(EDMS).
Act as a subject matter expert for the Veeva EDMS.
Ensure that all training requirements and curriculum is reviewed
within required intervals.
Ensure all GMP documentation is maintained and controlled per
company procedures.
Author procedural documents related to area of responsibility.
Monitor, track, and trend training.
Act as document control to route procedural documents in the Veeva
EDMS to ensure accuracy, completeness, and alignment with
procedures
Review new and revised procedures, ensuring document changes are
implemented into Petersburg procedures.
Minimum Qualifications (Knowledge, Skills, and Abilities)
Bachelor's degree with a minimum of 3 years training coordinator
and document control experience.
Strong project management, organization, and execution skills with
ability to managing multiple projects and priorities.
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; can learn by doing.
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.
PI201562091
Keywords: Civica Rx, Richmond , Training Development and Document Control Associate, Other , Petersburg, Virginia
Click
here to apply!
|