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Quality Assurance Specialist II

2 months ago


US Petersburg VA USA Civica Rx Full time
About Civica Rx

Civica Rx 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. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.

We are led by an experienced team of healthcare and pharmaceutical industry leaders, with a strong commitment to Do What Is in the Best Interest of Patients.

Job Description:Quality Assurance (QA) Compliance Specialist II

The QA Compliance Specialist II will join our team at the 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.

This role will 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. Responsibilities include leading activities related to supplier qualification, change control, investigations and CAPA, complaints, Quality Risk Management, inspection readiness and metrics.

Essential Duties and Responsibilities:
  • Implement and maintain the site's quality system framework, including quality systems and processes necessary to enable the development and reliable supply of Civica generic medications to patients.
  • Track, trend, and analyze quality processes and systems across the product lifecycle, including 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.
  • Ensure compliant document control and training programs.
  • Lead or participate in Quality Risk Management and Data Governance Processes as needed.
  • Support site objectives with a minimal amount of supervision.
  • Promote a quality mindset and quality excellence approach to all activities.
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.
  • 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.
Preferred Qualifications:
  • Experience with Veeva.
  • Yellow belt or other belt certification.