Training Specialist at Civica Rx

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 Training Specialist 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.

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.
• Collaborate across functional areas to develop and align the site training requirements.
• Ensure that all training requirements and curriculum is reviewed within required intervals.
• Ensure GMP training documentation is maintained and controlled per company procedures.
• Author procedural documents related to area of responsibility.
• Participate in activities to support regulatory agency inspections.
• Create dashboards and training reports within Veeva.
• 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.
• Support document control and other quality systems activities as needed.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• A minimum of four years' experience in the pharmaceutical or medical device industries.
• Bachelor or associate level degree in Pharmaceutical Sciences, Biology or related field preferred. High School degree with 6+ years of experience of cGMP production experience may be considered.
• 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.

Preferred Qualifications:

• Experience with Veeva.
• Yellow belt certification.