Specialist II, Quality Operations (3rd Shift) (Cincinnati, OH, US, 45241)

Cintrifuse; Cincinnati (OH); On-site; USD 65,000 - 85,000; Full time

Job summary

Cintrifuse is seeking a Quality Assurance professional for the third shift onsite in Cincinnati to perform Batch Disposition for Materials, Components, and Sub-Assemblies and support GMP/compliance on the production floor.

You will conduct Gemba walks, verify adherence to procedures, and serve as the quality contact for shift leads while aiding nonconformance programs and continuous improvement initiatives.

Qualifications

• Bachelor's degree or equivalent combination of education, training, and experience.
• Minimum 2 years of QA experience in the pharmaceutical or medical device industries.
• Experience in record review and material disposition is preferred.
• Experience in SAP or equivalent ERP system is preferred.

Responsibilities

• Performs Batch Disposition for Materials, Components, and Sub-Assemblies.
• Conducts routine Gemba walks and process audits on shift and documents observations.
• Acts as Quality point of contact for shift production leads and participates in handoffs and tier meetings.
• Serves as primary contact for production events; places product or material on hold when quality is impacted.
• Supports Nonconformance programs and assists Quality Management on compliance issues.

Skills

Quality Assurance

Communication

GMP/Regulatory

Microsoft Office

Databases/Excel

Auditing

Documentation

Problem solving

Education

Bachelor's Degree or equivalent

Job description

Location: Onsite

Status Type: Full Time

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

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., 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

Physical Requirements:

• 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

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