QA Compliance Specialist II

Petersburg, VA
November 16, 2024

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Job Description

About Civica

Civica, a 501(c)(4) social welfare organization founded in 2018, aims to alleviate chronic generic drug shortages and high prices in the U.S. Led by seasoned healthcare and pharmaceutical professionals, Civica has over 55 health systems as members, representing 1,500+ hospitals and one-third of U.S. hospital beds. The organization supplies essential medicines to the U.S. Department of Veterans Affairs, Department of Defense, and Strategic National Stockpile.

Recently, Civica announced CivicaScript, a unit focused on manufacturing affordable insulins for diabetes patients, set to launch in 2024. This initiative will help those struggling to afford life-saving medications.

Civica’s mission is to ensure accessible, affordable quality generic medications for all, guided by the principle of prioritizing patient interests. The Petersburg, Virginia facility, currently under construction, will produce affordable insulin and sterile injectable medicines.

For more on Civica’s impact on patient care, read the New England Journal of Medicine summary here. To learn about Civica’s affordable insulin plans, check out the article in BioSpace here.

Job Description:

The Quality Assurance (QA) Compliance Specialist II will join Civica’s Petersburg team, focusing on quality and compliance in the manufacture of essential generic sterile injectable medications.

Key responsibilities include:

  • Implementing and maintaining the site’s quality system framework.
  • Tracking and analyzing quality processes across the product lifecycle.
  • Leading supplier assessments and internal audits.
  • Identifying and resolving compliance issues collaboratively.
  • Supporting regulatory inspections and promoting a quality mindset.
  • Maintaining training procedures and delivering compliance training.
  • Limited travel may be required.

Basic Qualifications:

  • 6+ years in pharmaceutical or medical device manufacturing.
  • Experience in compliance and risk assessments.
  • Strong project management and problem-solving skills.
  • Excellent communication skills and proficiency in software applications.
  • Self-motivated and adaptable in a fast-paced environment.
  • Commitment to high-quality results and continuous learning.

Preferred Qualifications:

  • Experience with Veeva.
  • Yellow belt or other certification.

PandoLogic. Keywords: Regulatory Compliance Specialist, Location: Petersburg, VA – 23803, PL: 594917036