Quality Systems Specialist II – Data Integrity

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 leaders, 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 essential sterile injectables.

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 Systems Specialist II for Data Integrity will join Civica’s Petersburg team, contributing expertise in quality and compliance for the new fill-finish facility dedicated to essential generic sterile injectables.

Essential Duties and Responsibilities:

  • Maintain the data governance program, ensuring compliance with regulatory standards.
  • Mentor on quality management system procedures and data integrity.
  • Lead data integrity investigations and root cause analyses.
  • Support audit trail reviews and internal audits.
  • Analyze metrics for data governance effectiveness.
  • Deliver training on data integrity processes.
  • Promote a culture of quality and compliance.
  • Execute initiatives to enhance the quality system.
  • Perform additional duties as needed.

Basic Qualifications and Capabilities:

  • Bachelor’s degree with 6+ years in a GMP-related field.
  • Experience in quality systems, data integrity, and regulatory requirements.
  • Proven ability to lead investigations and risk assessments.
  • Familiarity with quality computerized systems (e.g., Veeva).
  • Strong communication and organizational skills.
  • Ability to work independently in a fast-paced environment.
  • Commitment to high-quality results and continuous learning.