Change Control & Process Improvement Lead (eQMS)

NEPHRON SC, LLC; West Columbia (TX); On-site; USD 90,000 - 110,000; Full time

Job summary

NEPHRON SC, LLC is seeking a Change Control Continuous Improvement Manager in Texas to lead optimization of change control and document revision processes within a regulated environment. You will drive data-driven improvements, KPI tracking, and cross-functional collaboration across Manufacturing, Engineering, Regulatory Affairs, and Quality.

You will serve as SME for eQMS platforms, develop training materials, and mentor staff on best practices for change control and document lifecycle

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field.
• 4+ years in QA, document control, or change control in regulated environments.
• Working knowledge of cGMP, FDA regulations, and data integrity.
• Proven experience with eQMS platforms and document lifecycle management.
• Strong written and verbal communication; detail-oriented.

Responsibilities

• Lead continuous improvement for change management from initiation to closure.
• Analyze data to identify bottlenecks and compliance risks.
• Set KPIs for cycle time, on-time closure, and rejection rates.
• Collaborate with Manufacturing, Engineering, Regulatory, Validation, and Quality.
• Perform root cause analysis and implement corrective improvements.
• Serve as SME for eQMS and train end users.

Skills

Quality systems

Process improvement

Data analysis

Cross-functional collaboration

Project management

Documentation

Regulatory compliance

Microsoft Office

Training/mentoring

Education

Bachelor's degree in Life Sciences / Pharmacy / Engineering

Tools

TrackWise

Dot Compliance

Veeva Vault

MasterControl

Adobe Acrobat

Excel

Job description

NEPHRON SC, LLC is seeking a Change Control Continuous Improvement Manager in Texas to lead optimization of change control and document revision processes within a regulated environment. You will drive data-driven improvements, KPI tracking, and cross-functional collaboration across Manufacturing, Engineering, Regulatory Affairs, and Quality.

You will serve as SME for eQMS platforms, develop training materials, and mentor staff on best practices for change control and document lifecycle