Quality Assurance Engineer II

5 days 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 are a 501(c)(4) organization established in 2018 by health systems and philanthropies. Our mission is to ensure that quality generic medications are accessible and affordable to everyone. Since our establishment, our #1 Policy has been to do what is in the best interest of patients.

Job Description

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

Responsibilities
  • Support quality systems and oversight to ensure the product process validation, cleaning validation, Quality Risk Management, and quality laboratory systems meet cGMP and Civica Rx compliance requirements.
  • Lead or participate in Quality Risk Management and analysis.
  • Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality-related matters is provided to the site.
  • Support and ensure compliance of product process transfers, including validation, from and/or to other manufacturing sites.
  • Lead activities related to product introduction to the site.
  • Support aseptic process simulations.
  • Support quality processes and systems across the product lifecycle, including change control, CAPA, deviations, and investigations, laboratory control, Annual Product Quality Review (APQR), and management notification.
  • Provide quality review and support for laboratory method validation/verification and laboratory information management system (LIMS).
  • Provide support to equipment, facilities, and utilities qualification as needed.
  • Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
  • Promote a quality mindset and quality excellence approach to all activities.
  • Promote a safety mindset and focus on safety for all operations activities.
Requirements
  • Bachelor's degree in a scientific discipline with 6+ years Quality/cGMP experience in the pharmaceutical industry.
  • Experience in process and cleaning validation, LIMS systems, aseptic process simulations, and Quality Risk Management.
  • Knowledge in 21CFR Part 11, Electronic Records and Signatures, and data integrity is required.
  • Strong project management, organization, and execution skills to manage multiple projects and priorities.
  • Participation and leading activities to support regulatory agency inspections is required.
  • Excellent interpersonal and written communication skills and experience using various software/electronic applications are 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.
  • Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.

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