Specialist I, Quality Operations

Parkview Medical Center, Inc.; Cincinnati (OH); On-site; USD 42,000 - 65,000; Full time

Job summary

Parkview Medical Center, Inc. is seeking a detail-oriented quality/compliance associate to support batch disposition, CAPA, and regulatory audits.

The role emphasizes maintaining quality documents, supporting management reviews, and ensuring regulatory compliance. The position requires a Bachelor's degree or equivalent, strong communication, problem-solving, and the ability to adapt to change under guidance.

Qualifications

• Bachelor’s Degree or equivalent combination of education, training, and experience.
• 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
• 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.
• Follow defined procedures
• Stay focused on tasks, organize, compare, interpret data, and assess problems with guidance.
• Work to acquire and develop new skills
• 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

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 qualitydocuments 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

Audit writing

Communication

Problem solving

Interpersonal

Regulatory understanding

Quality systems

Adaptability

Collaboration

Empathy & integrity

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Databases/Excel

Email scheduling software

Job description

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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


• 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

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 qualitydocuments 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