Quality Assurance Engineer II - Process and Validation (359)

Civica - Petersburg, VA

Full-time - Mid Level

Petersburg, VA

51-100 employees

Professional, Scientific, and Technical Services

About the position

The Quality Assurance Engineer II will join the Civica, Inc. Quality organization at the Petersburg, Virginia site, contributing their expertise to ensure the highest standards of quality and compliance in the manufacturing of essential generic sterile injectable medications. This role is pivotal in supporting quality systems and oversight to ensure that product process validation, cleaning validation, Quality Risk Management, and quality laboratory systems adhere to current Good Manufacturing Practices (cGMP) and Civica compliance requirements. The Petersburg facility is dedicated to the manufacture and supply of these critical medications, and the Quality Assurance Engineer will play a key role in the successful FDA approval of the facility and the introduction of new medications. The responsibilities of this position encompass a wide range of quality assurance activities. The engineer will work closely with validation and engineering teams to provide quality oversight for validation and qualification activities, ensuring that all work is performed in a compliant and controlled manner. This includes leading or participating in Quality Risk Management and analysis, maintaining up-to-date knowledge of local and international regulatory requirements, and providing expert advice on quality-related matters. The engineer will also support product process transfers, lead activities related to product introduction, and assist with aseptic process simulations. In addition to these responsibilities, the Quality Assurance Engineer II will support quality processes across the product lifecycle, including change control, Corrective and Preventive Actions (CAPA), deviations and investigations, laboratory control, and the Annual Product Quality Review (APQR). They will provide quality review and support for laboratory method validation and the laboratory information management system (LIMS). A proactive approach to problem-solving, a commitment to quality excellence, and a focus on safety in all operations are essential attributes for this role.

Responsibilities

• Support quality systems and oversight to ensure product process validation, cleaning validation, Quality Risk Management, and quality laboratory systems meet cGMP and Civica compliance requirements.
• Work with validation and engineering teams to provide Quality oversight for validation and qualification activities.
• Lead or participate in Quality Risk Management and analysis.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends.
• 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, and APQR.
• Provide quality review and support for laboratory method validation/verification and LIMS.
• 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 a minimum of 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 required.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications 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.

Nice-to-haves

• Technical expertise in sterile pharmaceutical isolator technology, combination product, and medical devices.