2nd-Shift Quality Operations Specialist

Cintrifuse; Cincinnati (OH); On-site; USD 65,000 - 85,000; Full time

Job summary

Cintrifuse is seeking a Quality Assurance professional to join our onsite Cincinnati team on the 2nd shift (M-F, 2:00 PM–10:30 PM EST). The role emphasizes batch disposition, process audits, and regulatory compliance in a pharmaceutical or medical device environment.

You will collaborate with production and quality teams to review records, maintain quality documentation, and support nonconformance programs while driving continuous improvement.

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.
• Serves as the Quality point of contact for shift production leads and participates in shift handoffs.
• 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

Quality Assurance

GMP/Regulatory knowledge

Documentation

Communication skills

Process auditing

Nonconformance management

Batch disposition

Gemba walks

Data interpretation

Team collaboration

Adaptability

Attention to detail

Education

Bachelor's Degree or equivalent

Tools

SAP

MS Office / Excel

Job description

Cintrifuse is seeking a Quality Assurance professional to join our onsite Cincinnati team on the 2nd shift (M-F, 2:00 PM–10:30 PM EST). The role emphasizes batch disposition, process audits, and regulatory compliance in a pharmaceutical or medical device environment.

You will collaborate with production and quality teams to review records, maintain quality documentation, and support nonconformance programs while driving continuous improvement.