QA Documentation Lead: MasterControl & Compliance Expert

Agupdate; Northern (KY); Hybrid; USD 78,000 - 102,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Tris Pharma, Inc. is seeking a Quality Assurance Documentation Lead to support and advance QA activities ensuring compliance with SOPs, cGMPs, and FDA standards.

The role involves assisting multiple departments, maintaining quality documentation, and supporting MasterControl systems to implement controlled changes. Fluency in English required; background checks may occur. Wage is listed with comprehensive benefits.

Qualifications

• Bachelor’s degree in Chemistry, Statistics, Biology or related field.
• 3+ years of QA/lab/manufacturing experience in pharma/biotech.
• Knowledge of cGMPs, SOPs and QA documentation practices.

Responsibilities

• Support QA functions to ensure manufacturing quality controls meet SOPs, cGMPs and FDA standards.
• Maintain and reconcile GxP records and quality documentation.
• Support MasterControl systems and documentation changes (DCRs, PKTs, specs, test methods, stability protocols, MBRs).
• Assist with data collection and APR reports across multiple departments.

Skills

cGMP knowledge

Quality documentation

MasterControl

Document control

MS Office

APR reporting

Team collaboration

Education

Bachelor’s degree in Chemistry, Statistics, Biology or related field

Tools

MasterControl

SLIM database

Job description

Tris Pharma, Inc. is seeking a Quality Assurance Documentation Lead to support and advance QA activities ensuring compliance with SOPs, cGMPs, and FDA standards.

The role involves assisting multiple departments, maintaining quality documentation, and supporting MasterControl systems to implement controlled changes. Fluency in English required; background checks may occur. Wage is listed with comprehensive benefits.