Quality Documentation Specialist

Role Summary The Quality Documentation Specialist maintains and elevates the site’s Quality Management System (ETQ) in full compliance with regulatory requirements and Colgate Quality Standards. Reporting to the Associate Manager, Quality Compliance, this role serves as a technical resource driving continuous improvement, key quality systems execution, and effective Management of Change (MOC) lifecycles. By maintaining audit readiness and site-wide compliance, this position directly impacts overall product quality and operational excellence across the manufacturing site.

Responsibilities

• Oversee and optimize site document control, record management, and Management of Change (MOC) systems to support compliance with cGMP, FSMA, and Colgate Quality Standards.

• Monitor and review daily, weekly, and monthly production records across physical and electronic data capture systems (MES/OPERA) to ensure complete audit readiness and timely finished product release.

• Track, analyze, and report site Quality KPIs—including product non-conformances, holds, customer complaints, and training compliance—to drive data-driven continuous improvement.

• Partner cross-functionally with site leadership, plant teams, and regulatory bodies to resolve technical compliance issues and support internal/external quality audits.

• Develop and deliver quality compliance training modules in collaboration with leadership to build site-wide technical proficiency and safety standards.

Required Qualifications

• Bachelor's degree

• 1+ years of experience in a manufacturing environment

• 1+ years of experience working with quality systems and Good Documentation Practices (cGMP)

• Demonstrated proficiency with enterprise document management systems and software (e.g., SAP, Google suite)

• Ability to lift up to 50 lbs and work flexible shifts (nights, weekends, holidays) to support operational needs

Preferred Qualifications

• Bachelor’s degree in Food Science, Engineering, Chemistry, Biology, Microbiology, or a related technical field

• 1+ years of quality experience specifically within a food or CPG manufacturing environment

• Active certifications such as PCQI, HACCP, or Certified Auditor

• Direct experience with regulatory and auditing bodies (e.g., FDA, USDA, SQF, AIB)

• Proficiency with statistical process control tools (e.g., SPC, Minitab)