Quality Associate

Employer
Civica Rx
Location
Lehi, UT
Salary
Salary DOE-Excellent Benefits
Posted
Jan 19, 2021
Required Education
Bachelors Degree
Position Type
Full time

WHY CIVICA?

Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica’s mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.

Because the United States experiences chronic shortages of essential generic medicines used daily in hospitals, we are building a state-of-the-art sterile injectable manufacturing facility to combat these shortages. This new facility is part of our broad strategy to stabilize the supply of generic medicines for emergency rooms, surgeries, COVID-19 patient care, and an array of other serious conditions.

WHO CIVICA SERVES

While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and “340B” hospitals caring for vulnerable patients in some of the country’s most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile.

With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs under contract by 2023.   


As we continue to grow, we have many exciting opportunities for multiple types of roles and with opportunity to progress YOUR career.

The Quality Associate will join the Civica, Inc. (“Civica”) team in Lehi, Utah 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 Quality, Regulatory and Compliance departments 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) in accordance with product specifications and SOPs
  • Assess and respond to product related complaints, investigation/deviation activities, perform root-cause analyses, and help to develop corrective and preventative action plans
  • Interface with customers to assess quality issues
  • Maintain change control tracking log
  • Support day to day operations of Civica's computerized serialization program
  • Review/approve serialization validation protocols/summary reports
  • Maintain, update, route and file controlled documents, as assigned
  • 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 similar field
  • A minimum of 2 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.