Specialist II, Quality Operations (2nd Shift)

Enable Injections Inc. • Sharonville, OH

2d • Onsite

About The Position

This is a full-time, onsite position for a Specialist II in Quality Operations, working the 2nd shift (Monday-Friday, 2:00 PM - 10:30 PM EST). The role involves performing batch disposition responsibilities for materials, components, and sub-assemblies, conducting routine Gemba walks and process audits, and serving as the Quality point of contact for shift production leads. The Specialist will also be the primary contact for production events, placing product or material on hold when quality is potentially impacted, and escalating issues per procedure. Responsibilities include supporting nonconformance programs, assisting Quality Management with compliance-related issues, ensuring product safety and regulatory compliance through proper management of quality documents and records, and developing or updating quality procedures and work instructions as needed. The role also focuses on identifying opportunities to reduce waste and improve efficiency.

Requirements

• 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
• Solid computer skills including Microsoft Office and databases/excel spreadsheets
• Good communication skills – verbal and written
• Understanding of Quality System requirements (i.e., nonconformances, GDP etc.) in a regulated medical device or pharmaceutical environment
• Good understanding of device and/or pharmaceutical regulatory and compliance requirements
• Ability to adapt to change and handle unexpected situations, requires occasional guidance.
• Shows inquisitiveness about how situations are evolving and identifies how to adapt early to changing situations.
• Ability to apply competency in difficult situations.
• Ability to follow defined procedures and proactively diagnose.
• Ability to stay focused on tasks, organize, compare, and interpret data and assess problems with little guidance.
• 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
• Ability to have a positive impact on others in support of company goals and a healthy work environment.
• Strong time management skills

Nice To Haves

• Experience in record review and material disposition
• Experience in SAP preferred or equivalent ERP system

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

What This Job Offers

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