Specialist I, Quality Operations

Enable Injections, Inc.; Cincinnati (OH); On-site; USD 45,000 - 60,000; Full time

Job summary

Enable Injections, Inc. is seeking a Specialist I in Quality Operations onsite in Cincinnati to support batch disposition, CAPA, and regulatory compliance. The role requires a bachelor’s degree or equivalent plus strong computer skills and the ability to work under guidance.

You will collaborate with cross-functional teams to ensure product quality and adherence to procedures and recordkeeping. This full-time position offers on-site work with room to develop skills in quality systems and

Qualifications

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

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

Job description

Title: Specialist I, Quality Operations

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

Nearest Major Market: Cincinnati