Title:  Specialist II, Quality Operations

QUALIFICATIONS

Required: 

• 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

Preferred:

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

Skills & Competencies:

• Solid computer skills including Microsoft Office and databases/excel spreadsheets
• Good communication skills – verbal and written
• Understanding of Quality System requirements (i.e., CAPA, nonconformances, etc.) in a regulated medical device or pharmaceutical environment
• Good understanding of device and/or pharmaceutical regulatory and compliance requirements

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. 

RESPONSIBILITIES:

• Performs Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies
• Assists with the assembly and execution of Management Reviews
• Responsible for supporting 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
• Develops or 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