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 Associate will join the Civica, Inc. (“Civica”) team in supplying essential generic quality medicines to our hospital members in the United States by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance.

The Quality Associate will provide the organization with quality related support for improving and maintaining the Civica Quality Management System (QMS) and ensure compliance to Food and Drug Administration (FDA) regulations and current good manufacturing practices (CGMPs). The Quality Associate's role will evolve to support ongoing supply, product launches and product development activities.

Essential Duties and Responsibilities:

• Perform batch review and disposition of finished product records for Private Label Distribution (PLD) and Civica contract manufacturer finished drug products in accordance with product specifications and SOPs
• Support Veeva Electronic Document Management System (eDMS) as a business administrator
• Serve as Veeva Training administrator
  • Work with hiring managers to determine appropriate Learner Roles and Training assignments
• Maintain, update, route, and electronically store controlled documents and metadata, as assigned
• Drive improvements and efficiencies to the document workflow process
• Assist in the development and use of document templates
• Assure controlled documents meet the defined standards
• Maintain change control tracking log
• Review/approve computerized systems validation protocols/summary reports
• Preparation of trend reports across Quality Systems, as needed
• Assist with continuous improvement initiatives across all GMP functions
• Provide support during internal and external audits and inspections
• Supports QA Manager in qualification and approval of suppliers and subcontractors
• Develop working knowledge of applicable regulatory, corporate and unit requirements
• Promotes a quality mindset and quality excellence approach to all activities
• Communicate effectively with co-workers, management and clients
• Additional duties as required to ensure appropriate quality practices

Basic Qualifications and Capabilities:

• Bachelor's degree in a scientific discipline, preferably in biology, engineering or a similar field
• A minimum of 3 years of working within the pharmaceutical or medical device industry, in a CGMP environment
• Promotes a quality mindset and quality excellence approach to all activities
• Quality Systems Experience in a CGMP environment
• Ability to organize, understand, and present complex scientific and technical information at a level that is appropriate for technical and non-technical backgrounds
• Attention to detail and analytical thinking
• Excellent interpersonal and organizational skills
• Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment
• Ability to work autonomously within established guidelines, procedures and practices
• Committed to delivering high quality results, overcoming challenges and focusing on what matters
• Continuously looking for opportunities to learn, build skills and share learning.

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