Specialist II, Quality Operations; 3rd Shift

Location: Onsite

Status Type: Full Time

Shift: 3rd Shift (M-F 10:00PM-6:30AM EST)

• 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

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

• 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

• Must be able to remain in a stationary position for extended periods of time
• Must be able to gown and work in a clean room 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

• 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