QA Specialist

Quality Assurance Specialist (QA Specialist)

Ohio, State

Ohio residents only (Submissions from third-party contractors, staffing agencies, vendors, or Corp-to-Corp (C2C) arrangements will not be considered)

Onsite

Immediate availability required

Our client is seeking a Quality Assurance Specialist to support a facility dedicated to the assembly and packaging of injectable medicines and medical devices. Reporting to the Senior Manager, the QA Specialist will provide quality oversight for facility and equipment design, installation, commissioning and qualification, and process validation. This role will also support the implementation and continuous improvement of Quality Management Systems (QMS), helping ensure compliant manufacturing operations, effective technology transfers, and sustainable site growth.

The ideal candidate will demonstrate strong critical-thinking skills, sound judgment, and a commitment to maintaining quality and compliance with Good Manufacturing Practices (GMP). This position requires regular onsite presence onsite, and immediate availability.

• Provide quality oversight and guidance for facility and equipment design, installation, commissioning, qualification, and process validation.
• Support the development, implementation, and continuous improvement of Quality Management Systems (QMS).
• Provide quality guidance to site partners to help maintain compliant commercial operations and support site growth and technology transfers.
• Support quality processes across manufacturing, warehousing, and Quality Assurance, including deviation management and change control.
• Review and approve validation documentation.
• Create, review, and approve Standard Operating Procedures (SOPs).
• Provide quality support for the creation of electronic batch records.
• Review and approve deviations and Corrective and Preventive Action (CAPA) records, as well as support batch disposition activities.
• Evaluate compliance issues, recommend appropriate actions, and monitor quality records through completion.
• Apply critical-thinking and problem-solving skills to maintain GMP compliance across operational areas and associated processes.

This role supports a facility focused on medical device assembly and the packaging of injectable medicines, using advanced assembly and packaging technologies and incorporating Industry 4.0 capabilities and sustainability initiatives.

• Must be a current Ohio resident.
• Must be available to start immediately.
• Must be able to work onsite in New Albany, Ohio.
• Must be comfortable providing quality oversight in a regulated manufacturing environment.
• Must demonstrate strong critical-thinking, problem-solving, and compliance-focused decision-making skills.