Quality Assurance Specialist

21 hours ago

Petersburg, United States BioSpace, Inc. Full time
Job Title: Quality Assurance Engineer

Civica, Inc. is seeking a highly skilled Quality Assurance Engineer to join our team at our Petersburg, Virginia site. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality and compliance of our products, including sterile injectable medications.

Responsibilities:
  • Maintain quality systems and oversight to ensure the validation/qualification and operation of laboratory processes, equipment, environmental monitoring, 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 facilities, laboratory operations, equipment, and instrumentation.
  • Work with validation, engineering, and laboratory teams to provide Quality oversight for 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 quality processes and systems across the product lifecycle, including change control, CAPA, deviations, and investigations.
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 of 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.
About Civica:

Civica 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 patients have access to affordable, high-quality medications.

We are committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters. If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.

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