Quality Assurance Engineer
12 hours ago
Civica is seeking a Quality Assurance Engineer to join our team at our Petersburg, Virginia site. As a Quality Assurance Engineer, you will be responsible for maintaining quality systems and oversight to ensure the validation/qualification and operation of computerized systems meet cGMP and Civica compliance requirements.
The ideal candidate will have a bachelor's degree in a scientific discipline or computerized systems with a minimum of 4+ years relevant experience. Experience providing computer system validation oversight, knowledge in 21CFR Part 11, Electronic Records and Signatures, and data integrity is required.
The Quality Assurance Engineer will work across functions to ensure the site's quality system processes related to GMP compliance of the facility, equipment, computer systems, and processes. They will also support implementation and quality oversight related to the overall compliance of the facility, equipment, and manufacturing processes.
The successful candidate will have strong project management, organization, and execution skills to manage multiple projects and priorities. They will also have excellent interpersonal and written communication skills and experience using various software/electronic applications.
Key Responsibilities:
- Maintain quality systems and oversight to ensure the validation/qualification and operation of computerized systems meet cGMP and Civica compliance requirements.
- Work across functions to ensure the site's quality system processes related to GMP compliance of the facility, equipment, computer systems, and processes.
- Support implementation and quality oversight related to the overall compliance of the facility, equipment, and manufacturing processes.
- Participate or lead in quality risk analysis.
- Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
Requirements:
- Bachelor's degree in a scientific discipline or computerized systems with a minimum of 4+ years relevant experience.
- Experience providing computer system validation oversight.
- Knowledge in 21CFR Part 11, Electronic Records and Signatures, and data integrity.
- Strong project management, organization, and execution skills to manage multiple projects and priorities.
- Excellent interpersonal and written communication skills and experience using various software/electronic applications.
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