Quality Assurance Engineer

4 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 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 - Facilities and Equipment 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. Our Petersburg site serves as our new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Key Responsibilities:
  • Maintain quality systems and oversight to ensure the validation/qualification and operation of process, facility, equipment, and computer systems meet cGMP and Civica compliance requirements.
  • Generate, review, and/or approve policies, procedures, reports, and other records necessary to provide quality oversight of Civica Engineering functions.
  • Work with validation and engineering teams to provide Quality oversight for validation and qualification activities and ensure work is performed in a compliant and controlled manner.
  • Support and ensure compliance of product and process transfers, including validation, from and/or to other manufacturing sites.
  • Support implementation and quality oversight related to the overall compliance of the facility, equipment, and manufacturing processes.
  • Support quality processes and systems across the product lifecycle, including change control, CAPA, deviations, and investigations.
  • Provide quality review and support for calibration and maintenance programs and ensure they are run in accordance with GMP regulation.
  • Participate in or lead quality risk analysis.
  • Proactively identify and work collaboratively to resolve problems 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 a minimum of 4 years Quality/cGMP experience in the pharmaceutical industry.
  • Experience in facility and equipment qualification, process validation, LIMS systems, and calibration and maintenance programs.
  • 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.
  • 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.
  • Serve as a Quality subject matter expert to support driving investigations to root cause.
  • Leverage experience and share industry best practices to support continuous improvement of site procedures.
  • Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
  • Continuously looking for opportunities to learn, build skills, and share knowledge with others.

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