Quality Operations Specialist II - 3rd Shift Onsite

Enable Injections, Inc.; Cincinnati (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Enable Injections, Inc. is seeking a Quality Assurance professional for an onsite role in Cincinnati, working the 3rd shift (M-F 10:00PM-6:30AM EST). The candidate should have a Bachelor’s degree or equivalent and at least 2 years in QA for pharma or medical devices, with SAP experience preferred.

The role focuses on batch disposition, process audits, and supporting nonconformance programs while ensuring regulatory compliance and product safety in a controlled environment.

Qualifications

• Bachelor’s degree or equivalent in a relevant field.
• Minimum 2 years in QA for pharma or medical devices.
• Experience with record review and material disposition preferred.
• Experience with SAP or ERP systems preferred.

Responsibilities

• Performs Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies
• Conducts routine Gemba walks and process audits on shift; documents observations
• Acts as Quality point of contact for production leads; participates in handoffs and tier meetings
• Primary contact for production events; places holds when quality is potentially impacted; escalates per procedure
• Supports Nonconformance programs
• Assists Quality Management on compliance issues
• Ensures product safety and regulatory compliance through management of quality documents and records
• Develops or updates quality procedures and work instructions
• Identifies opportunities to reduce waste and improve efficiency

Skills

MS Office

Data analysis

Communication skills

Regulatory knowledge

Quality Systems

Gowning/Cleanroom

Document control

Problem solving

Team collaboration

Time management

Adaptability

Positive attitude

Education

Bachelor's degree or equivalent

Tools

SAP

Job description

Enable Injections, Inc. is seeking a Quality Assurance professional for an onsite role in Cincinnati, working the 3rd shift (M-F 10:00PM-6:30AM EST). The candidate should have a Bachelor’s degree or equivalent and at least 2 years in QA for pharma or medical devices, with SAP experience preferred.

The role focuses on batch disposition, process audits, and supporting nonconformance programs while ensuring regulatory compliance and product safety in a controlled environment.