Quality Visual Inspector II (343)

Petersburg, VA

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 Visual Inspector will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site.  The Petersburg site serves as Civica’s new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.  Responsibilities of the position include performing visual inspections on filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP). 

Essential Duties and Responsibilities:

  • Visually inspects finished product vials and syringes for various defects.
  • Performs daily process activities, documents work accurately and timely in accordance with procedures, batch records and cGMPs.
  • Set up and adjusts operating equipment, such as inspection machines in accordance with procedures.
  • Performs and documents quality checks on products.
  • Calculates percent defects on inspection results and reconciles components.
  • Ability to complete eye exam and complete inspection certification.
  • Assists other process functions as required.
  • Proactively identify and work collaboratively to resolve problems.
  • Identifies areas for improvement and assists with writing SOPs and work instructions.

Basic Qualifications and Capabilities:

  • High School diploma or equivalent is required.
  • Must be able to complete eye exam.
  • 2+ years of experience performing inspections in a GMP environment.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
  • Effective organization skills and attention to detail.
  • Must be able to understand, speak, and write English in order to comply with necessary SOPs, SPECs, Job-specific training materials, GMPs, and other manuals. 
  • Basic math skills to perform required calculations (multiplication/division), 
  • Visual ability to detect defects. 
  • Good written and oral communication skills. 
  • Ability to work autonomously and within established guidelines, procedures, and practices.
  • Overtime, weekends and schedule adjustments may be required. 

Preferred Qualifications:

  • Experience in a sterile fill finish facility.
  • Visual inspection experience of vials and syringes.