Quality Assurance Specialist II

5 days ago

US Petersburg VA USA 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.

Our 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. Our manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines.

**Job Summary:**

The Quality Assurance (QA) Compliance Specialist II will join our team at the Petersburg, Virginia site by 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 (e.g., Current Good Manufacturing Practices, Good Distribution Practices), 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, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
  • 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. Appropriate combinations of experience and bachelor-level or higher education.
  • 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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