PCQI – Preventive Controls Qualified Individual

Position Title: Preventive Controls Qualified Individual (PCQI)

Department: Quality Assurance / Food Safety Reports To: Quality Manager / Food Safety Manager Location: Madison Heights,MI

🔹 Position Summary

The Preventive Controls Qualified Individual (PCQI) is responsible for developing, implementing, and maintaining the Food Safety Plan in compliance with FDA’s Preventive Controls for Human Food (21 CFR 117). The PCQI ensures that food safety hazards are identified, preventive controls are established, and verification/validation activities are properly documented.

🔹 Essential Duties & Responsibilities

Develop, prepare, and oversee the facility’s Food Safety Plan.

Conduct and document hazard analyses, including identifying biological, chemical, and physical hazards.

Establish, validate, and verify preventive controls such as process controls, allergen controls, sanitation controls, and supply-chain controls.

Review and approve monitoring and verification records.

Lead Corrective Actions and ensure timely documentation and follow-up.

Conduct environmental monitoring, product testing, and internal audits as required.

Maintain and update PCQI-required documentation and records for regulatory compliance.

Provide training to employees on food safety and GMPs.

Support regulatory inspections and customer audits.

Ensure conformance with FSMA, cGMPs, and company policies.

Investigate quality and food safety issues and implement effective preventive measures.

🔹 Qualifications

PCQI certification through an FDA-recognized training provider (FSPCA or equivalent).

1–3+ years of experience in food manufacturing, food safety, or quality assurance.

Knowledge of FSMA, GFSI schemes (SQF/BRC/IFS), HACCP principles, and cGMPs.

Strong analytical, communication, and documentation skills.

Ability to work in cross-functional teams and manage multiple tasks.

🔹 Physical Requirements

Ability to stand/walk in a manufacturing environment.

Ability to lift up to 50 lbs if required.

Must be able to work in cold, hot, or wet environments depending on facility conditions.

🔹 Work Environment

Manufacturing and office environments.

Exposure to allergens, noise, moving equipment, and sanitation chemicals.

🔹 Additional Preferred Skills

HACCP certification.

Experience with environmental monitoring programs.

Experience using food safety software or digital documentation systems.