Pharmaceutical Quality Assurance Specialist

1 week ago


Petersburg, Virginia, United States Civica Rx Full time

Civica Rx is a leading social welfare organization dedicated to reducing generic drug shortages and related high prices in the United States.

As a QA Operations Specialist, you will join our team at the Petersburg, Virginia site and contribute to the manufacture and supply of essential generic sterile injectable medications.

This role is critical in ensuring that our manufacturing and operations activities comply with applicable regulatory standards, such as Current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP).

Your responsibilities will include reviewing and approving materials, bill of materials, batch records, and GMP documentation to support the design, implementation, and maintenance of manufacturing processes that meet or exceed FDA requirements.

Key Responsibilities:

  • Quality Operations: Review and approve materials, bill of materials, batch records, and GMP documentation to ensure compliance with cGMP and GDP.
  • Manufacturing Batch Record Design: Partner with operations to develop manufacturing batch records that meet regulatory and company requirements.
  • Defect Criticality Assessment: Determine defect criticality, inspection methods, and training plans for QA Operations and Manufacturing employees.
  • Process Limit Establishment: Collaborate with MSAT and Operations to establish process limits for manufacturing processes such as filling and packaging.
  • Quality Risk Management: Participate in Quality Risk Management Processes as needed.
  • Safety and Quality Mindset: Promote a safety and quality-first mindset in daily job functions.

About Us:

Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.

We are seeking an experienced QA Operations Specialist to join our team at the Petersburg, Virginia site. This role offers a competitive salary range of $85,000 - $110,000 per year, depending on experience, plus benefits and opportunities for growth and development.



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