Research Operations Lead, Quality Systems (cGMP)

The University of North Carolina at Chapel Hill; North Carolina; On-site; USD 85,000 - 112,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

The University of North Carolina at Chapel Hill is seeking a Research Operations Manager for the Advanced Cellular Therapeutics Facility to uphold Quality Systems and cGMP compliance. You will lead a team responsible for batch review, investigations, CAPA, change controls, and document management to ensure patient-ready products.

Ideal candidates have a Bachelor’s degree with 2 years of research experience, leadership experience, and strong Word/Excel skills, plus ability to train staff and

Qualifications

• Bachelor’s degree and two years of general research experience or equivalent.
• Knowledge of Quality Systems in a cGMP manufacturing facility.
• Leadership experience and ability to manage employees; strong communication and data analysis skills.

Responsibilities

• Oversee Quality Systems including batch review and release for distribution to patients.
• Lead investigations, CAPA, change controls, validations, stability, and document changes.

Skills

Leadership

Data analysis

Quality Systems

CAPA investigations

Excel

Technical writing

Training

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

Job description

The University of North Carolina at Chapel Hill is seeking a Research Operations Manager for the Advanced Cellular Therapeutics Facility to uphold Quality Systems and cGMP compliance. You will lead a team responsible for batch review, investigations, CAPA, change controls, and document management to ensure patient-ready products.

Ideal candidates have a Bachelor’s degree with 2 years of research experience, leadership experience, and strong Word/Excel skills, plus ability to train staff and