Quality Engineer III

About the role

The Quality Engineer III – Process Validation provides quality assurance leadership across the full product lifecycle, from New Product Introduction (NPI) and Process Performance Qualification (PPQ) through commercial manufacturing. This role ensures programs are compliant, inspection-ready, and aligned with commercialization quality strategies, while partnering closely with cross-functional teams to support successful product launches and sustained commercial operations in a regulated GMP environment. This is a Contract to Hire position based out of Saint Louis, MO, working in a fast‑paced biologic drug substance manufacturing facility focused on cell process development to support both clinical and commercial manufacturing.

Responsibilities

• Serve as the Quality representative and lead on cross‑functional program teams to support commercialization readiness from late‑stage development through product launch and post‑launch support.
• Provide phase‑appropriate QA oversight for technology transfer activities, including process validation and PPQ readiness, control strategy implementation, and manufacturing scale‑up.
• Partner with product and program leadership to ensure quality deliverables, timelines, and risk mitigations are fully integrated into program plans, including risk assessments, readiness reviews, and documentation strategies.
• Ensure alignment with applicable regulations and guidance, such as FDA, EMA, and ICH, as well as internal site quality standards.
• Review and approve GMP documentation, including batch records, standard operating procedures (SOPs), technical reports, and quality records such as work notifications.
• Support material disposition and product release activities by applying appropriate quality oversight and decision‑making.
• Conduct compliance walkthroughs on the manufacturing floor to verify adherence to GMP standards and identify areas for improvement.
• Provide QA support during manufacturing hypercare periods and critical operations, ensuring issues are promptly identified and addressed.
• Support and lead investigations for deviations, corrective and preventive actions (CAPAs), and change controls, including root cause analysis and documentation.
• Apply risk‑based decision‑making to ensure outcomes are both compliant and effective, balancing quality requirements with operational realities.
• Identify, assess, and mitigate quality risks across operations, proactively addressing potential issues before they impact product quality or compliance.
• Contribute to continuous improvement initiatives by recommending and implementing enhancements to quality systems, processes, and documentation.
• Provide on‑floor QA oversight over manufacturing processes, including review and approval of batch records and support for process validation and PPQ activities.
• Utilize tools such as Smartsheet and audit practices to track, manage, and report on quality‑related activities and documentation.
• Communicate clearly with internal and external stakeholders, documenting and