Specialist II, Quality Operations (2nd Shift)

Parkview Medical Center, Inc.; Cincinnati (OH); Híbrido; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

Parkview Medical Center, Inc. is hiring a Specialist II, Quality Operations for the 2nd Shift on site in Cincinnati, OH.

The role supports quality assurance in a regulated medical device/pharmaceutical environment, performing batch dispositions, process audits, and leading quality communications on the shift. The ideal candidate has a Bachelor’s degree and at least two years of QA experience, with strong regulatory knowledge and collaboration skills to drive continuous improvement and compliance

Formación

• Bachelor’s Degree or equivalent combination of education, training, and experience.
• Minimum 2 years of experience in Quality Assurance for pharmaceutical or medical device industries.

Responsabilidades

• Performs Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies.
• Performs routine Gemba walks and process audits on shift to verify adherence to procedures.
• Serves as the Quality point of contact for shift production leads and passes open issues.
• Primary contact for production events; places product on hold when quality is impacted.
• Supports Nonconformance programs.
• Guides compliance issues; ensures product safety and regulatory compliance.
• Develops or updates quality procedures and work instructions as needed.
• Identifies opportunities to reduce waste and improve efficiency.

Conocimientos

Microsoft Office

Databases / Excel

Verbal & written communication

Quality System knowledge

Regulatory compliance

Adaptability

Data interpretation

Collaboration

Time management

Cross-functional teamwork

Educación

Bachelor’s Degree or equivalent

Herramientas

SAP

ERP system

Descripción del empleo

Title: Specialist II, Quality Operations (2nd Shift)

Description

Location: Onsite

Status Type: Full Time

Shift: 2nd Shift (M-F 2:00PM-10:30PM 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 issuesEnsures 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