Change Control & Process Improvement Lead (eQMS)

Nephron Pharmaceuticals Corporation; Columbia (SC); On-site; USD 90,000 - 130,000; Full time

Job summary

Nephron Pharmaceuticals Corporation seeks a Change Control Continuous Improvement Manager to optimize document control and change workflows within the eQMS. You will lead improvement initiatives, analyze KPIs, and collaborate with Manufacturing, Regulatory Affairs, Validation, and Quality to ensure compliant, efficient processes.

The role requires expertise in document lifecycle management, cGMP, and experience with TrackWise and Dot Compliance.

Qualifications

• Associate or Bachelor’s degree in a related field.
• 3–4 years in document control and/or QA in a regulated environment.
• Strong knowledge of cGMP and FDA regulations.
• Experience with eQMS platforms and document lifecycle management.
• Ability to lead continuous improvement initiatives within a quality systems function.

Responsibilities

• Lead continuous improvement for change management processes from initiation to closure.
• Analyze data to identify bottlenecks and compliance risks.
• Establish KPIs for change control and document revision performance.
• Collaborate with Manufacturing, Engineering, Regulatory Affairs, Validation, and Quality.
• Develop and deliver training on document and change control processes.

Skills

Continuous Improvement

Change Control

eQMS

Data Analysis

Training & Mentoring

Documentation

Project Management

Regulatory Knowledge

Communication

Cross-functional Collaboration

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Business Administration, or related field

4–6 years in QA/Document Control/Change Control

Tools

TrackWise / TrackWise Digital

Dot Compliance

Veeva Vault / MasterControl

Microsoft Office (Word, Excel, PowerPoint)

Job description

Nephron Pharmaceuticals Corporation seeks a Change Control Continuous Improvement Manager to optimize document control and change workflows within the eQMS. You will lead improvement initiatives, analyze KPIs, and collaborate with Manufacturing, Regulatory Affairs, Validation, and Quality to ensure compliant, efficient processes.

The role requires expertise in document lifecycle management, cGMP, and experience with TrackWise and Dot Compliance.