GMP Quality Assurance Specialist - Onsite, Immediate Start

ProQuality Network; Ohio; On-site; USD 65,000 - 85,000; Full time

Job summary

ProQuality Network is seeking a Quality Assurance Specialist to support an injectable medicines and medical devices packaging facility in Ohio. You will oversee facility and equipment validation, contribute to QMS implementation, and guide site partners to maintain GMP-compliant operations.

The ideal candidate demonstrates strong critical-thinking, judgment, and compliance-focused decision-making, with a readiness for immediate onsite work in New Albany, OH.

Qualifications

• 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.

Responsibilities

• 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.

Job description

ProQuality Network is seeking a Quality Assurance Specialist to support an injectable medicines and medical devices packaging facility in Ohio. You will oversee facility and equipment validation, contribute to QMS implementation, and guide site partners to maintain GMP-compliant operations.

The ideal candidate demonstrates strong critical-thinking, judgment, and compliance-focused decision-making, with a readiness for immediate onsite work in New Albany, OH.