Quality Operations Specialist II — 2nd Shift (GMP/Pharma)

Enable Injections, Inc.; Cincinnati (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

Enable Injections, Inc. is hiring for a Quality Assurance professional in Cincinnati to support batch disposition and QA processes on the 2nd shift. The role requires collaboration with production teams and strict adherence to regulatory standards in a clean-room environment.

The candidate should have a bachelor’s degree or equivalent, plus at least 2 years of QA experience in pharma or medical devices. Familiarity with SAP and strong communication skills are preferred.

Qualifications

• Bachelor’s degree or equivalent combination of education, training, and experience.
• Minimum 2 years of experience in Quality Assurance for the pharmaceutical or medical device industries.

Responsibilities

• Performs Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies.
• Performs routine Gemba walks and process audits on shift to verify adherence to approved procedures and work instructions. Documents and reports observations.
• Serves as the Quality point of contact for shift production leads. Participates in shift handoffs and tier meetings, and passes open quality issues to other shifts.
• Primary contact for production events; places product or material on hold when quality is potentially impacted, and escalates per procedure
• Responsible for supporting Nonconformance programs
• Assists Quality Management in providing guidance on compliance related issues
• Ensures product safety, regulatory compliance, and compliance through proper management of quality documents and quality records
• Develops or updates quality procedures and work instructions, when required
• Identifies areas of opportunity to reduce waste and improve efficiency

Skills

Microsoft Office

Databases/Excel

Communication skills

Quality system knowledge

Regulatory/compliance

Time management

Team collaboration

Education

Bachelor’s degree

Tools

SAP

Job description

Enable Injections, Inc. is hiring for a Quality Assurance professional in Cincinnati to support batch disposition and QA processes on the 2nd shift. The role requires collaboration with production teams and strict adherence to regulatory standards in a clean-room environment.

The candidate should have a bachelor’s degree or equivalent, plus at least 2 years of QA experience in pharma or medical devices. Familiarity with SAP and strong communication skills are preferred.