Specialist I, Quality Operations

Enable Injections Inc. • Sharonville, OH

20h • Onsite

About The Position

This role is responsible for assisting with various quality operations tasks, including batch disposition, management reviews, and supporting corrective and preventive actions. The Specialist will ensure product safety and regulatory compliance through proper management of quality documents and records. They will also identify opportunities for waste reduction and efficiency improvement, and provide assistance during audits.

Requirements

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

Nice To Haves

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level