Specialist II, Quality Operations (3rd Shift)

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