Quality Assurance Specialist II — Night Shift

Cintrifuse; Cincinnati (OH); On-site; USD 65,000 - 105,000; Full time

Job summary

CCCinTRIFUSE Cincinnati is seeking a Quality Assurance professional to handle batch disposition for materials, components, and sub-assemblies on the onsite 3rd shift. You will conduct routine audits, act as the QA point of contact for production leads, and escalate quality issues per procedure.

You will support nonconformance programs and help ensure regulatory compliance and proper documentation. Strong communication and GMP knowledge are essential for success.

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

Quality Assurance

GMP/Regulatory compliance

Communication skills

Attention to detail

Adaptability to change

Data interpretation

Time management

Team collaboration

Problem solving

Positive attitude

Education

Bachelor's Degree or equivalent

Tools

SAP

Job description

CCCinTRIFUSE Cincinnati is seeking a Quality Assurance professional to handle batch disposition for materials, components, and sub-assemblies on the onsite 3rd shift. You will conduct routine audits, act as the QA point of contact for production leads, and escalate quality issues per procedure.

You will support nonconformance programs and help ensure regulatory compliance and proper documentation. Strong communication and GMP knowledge are essential for success.