Quality Assurance Specialist II

3 weeks ago

Washington, Washington, D.C., United States Civica Rx Full time
About Civica Rx

Civica Rx is a leading social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our team of experienced healthcare and pharmaceutical industry leaders is committed to ensuring that quality generic medications are accessible and affordable to everyone.

We have established a strong presence in the industry, with over 55 health systems joining our organization, representing over 1,500 hospitals and one-third of all U.S. hospital beds. We have 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.

Our mission is to ensure that quality generic medications are accessible and affordable to everyone. We are committed to doing what is in the best interest of patients and have established a strong quality system framework to support our mission.

Job Description:

The Quality Assurance (QA) Compliance Specialist II will join our team at our Petersburg, Virginia site, bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as our new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

**Key Responsibilities:**

  • Lead aspects of quality and compliance to ensure compliance with applicable regulatory standards, internal standards, and expectations for the development and reliable supply of quality medicines.
  • Implement, track, trend, and analyze quality processes and systems across the product lifecycle, including change control, CAPA, deviations, and investigations.
  • Lead the assessment, qualification, and approval of suppliers.
  • Participate in or lead internal self-assessment audits.
  • Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
  • Working across functions to ensure compliant document control and training programs.
  • Lead or participate in Quality Risk Management and Data Governance Processes as needed.
  • Participate in activities to support regulatory agency inspections.
  • Support site objectives with a minimal amount of supervision.

**Basic Qualifications and Capabilities:**

  • 6+ years' experience working directly with manufacturing in the pharmaceutical or medical device industries.
  • Demonstrated experience conducting and writing compliance and/or risk assessments.
  • Project management, organization, and execution skills are required.
  • Ability to apply technical expertise to solve problems and issues.
  • Participating in and leading activities that support regulatory agency inspections is required.
  • Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
  • Ability to work autonomously and within established guidelines, procedures, and practices.

**Preferred Qualifications:**

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

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