Senior QA Specialist II: Quality Assurance Leader

Resilience; Blue Ash (OH); On-site; USD 90,000 - 124,000; Full time

Benefits offered by this job

Annual cash bonus program

401(k) plan with generous match

Healthcare benefits package

Paid vacation and holidays

Tuition reimbursement

Job summary

Resilience is seeking a Senior Specialist II in Quality Assurance to oversee pharmaceutical and combination product quality across inspection, assembly, packaging, and release activities in Blue Ash. The role ensures cGMP compliance, regulatory alignment, and robust QA processes.

You will lead cross‑functional QA initiatives, perform complex investigations, and provide technical guidance during audits and regulatory inspections, driving process improvements and product quality.

Qualifications

• Advanced technical expertise in qualification of equipment, utilities, facilities, technology transfer, statistical analysis, investigation techniques, risk management, and process validation.
• Knowledge of regulatory guidance related to technology transfer and validation.
• Ability to apply regulatory requirements in a regulated environment (21 CFR, ISO, EMA, etc.).

Responsibilities

• 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.
• Providing on‑site support and acting as SME during audits and inspections.
• Quality oversight for manufacturing, laboratory, and quality system activities, including batch disposition and CAPAs.
• Reviewing and approving quality documentation and quality metrics.
• Collaborating with MSAT, Project Management, Engineering, and other departments to ensure seamless integration of new products and technologies into the manufacturing process.
• Leading risk assessments and implementing corrective actions while driving continuous improvement.
• Training and mentoring junior QA staff and non‑QA partners.

Skills

Quality assurance leadership

cGMP

Regulatory compliance

Root cause analysis

Documentation

Audit support

Cross-functional collaboration

Risk assessment

Education

Bachelor’s degree in Pharmaceutical Sciences/Chemistry/Engineering

Tools

SAP

MAXIMO

CMMS

Electronic quality management systems

Job description

Resilience is seeking a Senior Specialist II in Quality Assurance to oversee pharmaceutical and combination product quality across inspection, assembly, packaging, and release activities in Blue Ash. The role ensures cGMP compliance, regulatory alignment, and robust QA processes.

You will lead cross‑functional QA initiatives, perform complex investigations, and provide technical guidance during audits and regulatory inspections, driving process improvements and product quality.