Senior Specialist, Quality Assurance

Resilience US; Blue Ash (OH); On-site; USD 100,000 - 140,000; Full time

Job summary

Resilience US in Blue Ash, OH seeks a Senior Specialist, Quality Assurance to lead QA oversight across manufacturing, inspection, and packaging. The role ensures cGMP compliance and supports product release activities, with collaboration across departments to improve quality and process efficiency.

The ideal candidate brings strong QA leadership, regulatorily aware mindset, and experience with audits, investigations, and continuous improvement in a pharmaceutical environment.

Qualifications

• Strong QA oversight across manufacturing and QC.
• Experience with cGMP and regulatory standards.
• Knowledge of 21 CFR 210, 211, 4, 820, ISO 13485, ISO 14971, EMA, PDA, ICH.
• Experience with design controls and change management.
• Leadership and cross-functional collaboration.

Responsibilities

• Provide quality oversight and approval for manufacturing, laboratory, and quality system activities.
• Ensure compliance with cGMP and regulatory standards through documentation reviews and quality systems monitoring.
• Review initial impact assessments to classify deviations.
• Support investigations with root cause analyses and CAPAs.
• Act as Quality SME for cross‑functional projects, audits, and regulatory interactions.
• Review and maintain quality documents, records, and validation materials.
• Support incoming material quality activities including inspection and release decisions.
• Collaborate with Manufacturing, Technical Operations, Supply Chain, and Quality teams.

Skills

Quality Assurance

Regulatory compliance

cGMP

Leadership

Audits & inspections

Tools

SAP

MAXIMO

CMMS

Electronic quality management systems

Job description

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made . We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary

The Senior Specialist, Quality Assurance (Blue Ash), is responsible for providing quality oversight and operational support across inspection, assembly, packaging, incoming quality control, and product release activities. This role ensures compliance with cGMP, regulatory requirements, and internal quality standards by providing quality oversight of pharmaceutical and combination product inspection, assembly, and packaging operations. 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 strong technical expertise, sound quality systems knowledge, and the ability to effectively collaborate across functional areas to support the manufacture and release of pharmaceutical and combination products.

Responsibilities

• Provide 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.
• Ensure 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.
• Perform reviews and approvals of investigation initial impact assessments to determine the classification of deviations.
• Support investigations to include; root cause analyses, and resolution of product quality issues, implementing effective corrective and preventive actions while driving continuous improvement initiatives.
• Serve as the Quality representative and subject matter expert for cross-functional projects, technology transfers, process improvements, audits, inspections, and regulatory interactions.
• Review, approve, and maintain quality documentation, records, procedures, specifications, validation documents, and quality metrics to ensure accuracy, completeness, and compliance.
• Support incoming material and component quality activities, including inspection, sampling, testing, and release decisions, while ensuring adherence to established quality standards.
• Partner with Manufacturing, Technical Operations, Supply Chain, and Quality teams to ensure consistent execution of quality systems, successful project delivery, and uninterrupted product flow.
• Provide technical guidance, training, and direction to technicians and team members, promoting compliance, operational excellence, and a culture of quality.
• Utilize quality and business systems (e.g., SAP, MAXIMO, CMMS, electronic quality management systems) to support documentation, inventory management, data analysis, metrics reporting, and quality decision-making.
• Collaborate with MSAT, Project Management, Engineering, and other departments to ensure seamless integration of new products and technologies into the manufacturing process.
• Assist in the review and approval of new product introductions, ensuring quality standards are met throughout the product lifecycle.
• Lead risk assessments (e.g. pFMEA) and implement strategies for mitigating technical and quality risks associated with manufacturing processes.

Minimum Qualifications

Strong technical experience in the qualification of equipment, utilities, facilities, technology transfer, statistical analysis, investigation techniques, development, and risk management methodology and process validation, and/or Quality oversight in these disciplines.

Thorough knowledge of current industry best practices and regulatory guidance expectations regarding technology transfer and validation.

Demonstrated experience in a regulated environment (21 CFR 210, 211, 4, 820, ISO 13485, ISO 14971, EMA, PDA, ICH, etc.)

Knowledge of Design Controls and experience with change management

Strong leadership, relationship management, and organizational planning.

Experience supporting audits and regulatory inspections.

Experience using risk assessment tools (e.g. Failure Modes and Effects Analysis (FMEA), Hazard Analysis and Critical Control Poi