Specialist I, Quality Operations (Cincinnati, OH, US, 45241)

Cintrifuse; Cincinnati (OH); On-site; USD 42,000 - 66,000; Full time

Job summary

Cintrifuse is seeking a qualified QA professional to oversee batch disposition, CAPA, and documentation to ensure regulatory compliance and product safety at our onsite Cincinnati facility.

The role emphasizes adherence to procedures, data interpretation, and collaboration with cross-functional teams to drive quality improvements and efficient audits.

Qualifications

• Bachelor’s Degree or equivalent combination of education, training, and experience.
• Audit report writing skills
• Strong communication skills – verbal and written
• Some understanding of device and/or pharmaceutical regulatory and compliance requirements
• Understanding of product complaint requirements

Responsibilities

• Assist with Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies
• Assists with the assembly and execution of Management Reviews
• Support Corrective and Preventive (CAPA) and 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
• Updates quality procedures and work instructions, when required
• Identifies areas of opportunity to reduce waste and improve efficiency
• Assist with Management Review metrics and documentation
• Provides assistance during Regulatory and customer audits

Skills

Microsoft Office

Excel

Email scheduling

Adaptability

Procedures

Data interpretation

Time management

Collaboration

Enable Values

Empathy

Positive attitude

Education

Bachelor's Degree or equivalent

Tools

Email/Scheduling software

Job description

Location

Onsite

Status Type

Full Time

Qualifications

Required: Bachelor’s Degree or equivalent combination of education, training, and experience.

Preferred:

• Audit report writing skills
• Strong communication skills – verbal and written
• Strong problem-solving skills
• Strong interpersonal skills
• Understanding of product complaint requirements
• Some understanding of device and/or pharmaceutical regulatory and compliance requirements

Skills & Competencies

• Strong computer skills including Microsoft Office and databases/excel spreadsheets
• Knowledge of e-mail/scheduling software application
• Ability to learn and utilize future software/applications as it is deployed
• Ability to adapt to change and handle unexpected situations with close guidance.
• Accepts direction on how to adapt approach to changing situations.
• Ability to follow defined procedures
• Ability to stay focused on tasks, organize, compare, interpret basic data, and assess problems with guidance.
• Work to acquire and develop new skills
• Ability to collaborate and maintain cooperative work relationships with others.
• Engages colleagues with the Enable Values in mind
• Ability to maintain a positive attitude, show empathy for others, and always do the right thing
• Good time management skills

Physical Requirements

• Must be able to remain in a stationary position for extended periods of time
• Ability to lift and lower boxes of documents or handle equipment weighing up to 25 lbs.
• Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
• Position requires being physically present on the premises during regular company hours or as approved by management.

Responsibilities

• Assist with Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies
• Assists with the assembly and execution of Management Reviews
• Support Corrective and Preventive (CAPA) and 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
• Updates quality procedures and work instructions, when required
• Identifies areas of opportunity to reduce waste and improve efficiency
• Assist with Management Review metrics and documentation
• Provides assistance during Regulatory and customer audits