Specialist II, Quality Operations (3rd Shift)

Enable Injections, Inc.; Cincinnati (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Enable Injections, Inc. is seeking a Quality Assurance professional for an onsite role in Cincinnati, working the 3rd shift (M-F 10:00PM-6:30AM EST). The candidate should have a Bachelor’s degree or equivalent and at least 2 years in QA for pharma or medical devices, with SAP experience preferred.

The role focuses on batch disposition, process audits, and supporting nonconformance programs while ensuring regulatory compliance and product safety in a controlled environment.

Qualifications

• Bachelor’s degree or equivalent in a relevant field.
• Minimum 2 years in QA for pharma or medical devices.
• Experience with record review and material disposition preferred.
• Experience with SAP or ERP systems preferred.

Responsibilities

• Performs Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies
• Conducts routine Gemba walks and process audits on shift; documents observations
• Acts as Quality point of contact for production leads; participates in handoffs and tier meetings
• Primary contact for production events; places holds when quality is potentially impacted; escalates per procedure
• Supports Nonconformance programs
• Assists Quality Management on compliance issues
• Ensures product safety and regulatory compliance through management of quality documents and records
• Develops or updates quality procedures and work instructions
• Identifies opportunities to reduce waste and improve efficiency

Skills

MS Office

Data analysis

Communication skills

Regulatory knowledge

Quality Systems

Gowning/Cleanroom

Document control

Problem solving

Team collaboration

Time management

Adaptability

Positive attitude

Education

Bachelor's degree or equivalent

Tools

SAP

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
• - 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