Senior Specialist II, Quality Assurance

Position Summary

The Senior Specialist II, Quality Assurance (Blue Ash), is responsible for providing technical and operational quality oversight and support across inspection, assembly, packaging, incoming quality control, and product release activities. This role ensures compliance with cGMP, regulatory requirements, and internal quality standards through oversight of the inspection, assembly, and packaging of pharmaceuticals and combination products. This position requires a blend of strong technical expertise, quality assurance knowledge, and leadership capabilities to effectively collaborate across departments and lead initiatives that enhance product quality and process efficiency.

Responsibilities include performing and overseeing production processes, sampling and testing activities, maintaining quality records and documentation; supporting technology and design transfers; troubleshooting quality-related issues, material and batch disposition, and providing guidance to cross‑functional teams to ensure successful execution of quality objectives. This role requires advanced technical expertise, to be able to provide quality oversight of validation, investigations, change controls, and technology/design transfer.

They may work independently or lead specialized projects, providing high‑level strategic insight and technical advice.

• Performing and overseeing production processes, sampling and testing activities, maintaining quality records and documentation.
• Supporting technology and design transfers.
• Troubleshooting quality-related issues, material and batch disposition.
• Providing guidance to cross‑functional teams to ensure successful execution of quality objectives.
• Providing quality oversight for complex and/or higher‑level investigations, change controls, validation protocols, and technology transfer documents, ensuring adherence to established specifications, procedures, and regulatory requirements.
• Providing technical quality oversight, review, and approval of complex and higher‑level validation documents including validation plans, requirement documents (URS, FS, SRA, SLIA, and ACA), protocols, data analysis, discrepancies, and final reports.
• Providing hands‑on support and act as an SME and/or host during internal, regulatory, and customer audits and inspections.
• Providing quality oversight and approval for manufacturing, laboratory, and quality system activities, including batch disposition, material sampling and disposition, investigations, deviations, CAPAs, change controls, risk assessments, and validation activities.
• Ensuring compliance with cGMP requirements and applicable regulatory standards through review of documentation, monitoring of quality systems, and support of inspection, assembly, packaging, testing, and release operations.
• Performing reviews and approvals of investigation initial impact assessments to determine the classification of deviations.
• Supporting of these investigations will also include collaboration during root cause analyses sessions, resolution of product quality issues, and implementing effective corrective and preventive actions while driving continuous improvement initiatives.
• Serving as the Quality representative and subject matter expert for cross‑functional projects, technology transfers, process improvements, audits, inspections, and regulatory interactions.
• Reviewing, approving, and maintaining quality documentation, records, procedures, specifications, validation documents, and quality metrics to ensure accuracy, completeness, and compliance.
• Supporting incoming material and component quality activities, including inspection, sampling, testing, and release decisions, while ensuring adherence to established quality standards.
• Partne…