Specialist I, Quality Operations (Cincinnati, OH, US, 45241)
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At a glance
Requirements
Credentials this posting asks for.
Job overview
Enable Injections is hiring a Specialist I, Quality Operations (Cincinnati, OH, US, 45241). The Quality Operations Specialist I assists with batch disposition, management reviews, and supports CAPA and nonconformance programs. This role ensures product safety and regulatory compliance through proper management of quality documents and records. The specialist also updates quality procedures, identifies areas for improvement, and provides assistance during audits.
Key focus areas include Assist with Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies, Assist with the assembly and execution of Management Reviews, and Support Corrective and Preventive (CAPA) and Nonconformance programs.
Successful candidates bring Bachelor's Degree Or Equivalent. Preferred (not required): Audit Report Writing, Communication, Problem-Solving, and Interpersonal Skills.
Skills & qualifications
Skills
Qualifications
Full 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
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