PCQI Document Control Specialist

Description

PCQI / Document Control Specialist

Location: Avenel / Piscataway
Position Type: Full-Time
Reports To: Quality Manager / Director of Quality Assurance

About the Role:

We are seeking a detail-oriented and highly organized PCQI / Document Control Specialist to support our Quality and Food Safety programs. In this dual-role position, you will maintain oversight of our Preventive Controls Food Safety Plan while managing the company’s document control system to ensure full compliance with FDA, FSMA, and applicable third-party certification standards. This role involves gathering, maintaining, and updating essential documents from vendors.

Key Responsibilities:

• Develop, maintain, and verify the facility’s Food Safety Plan as the designated PCQI.
• Conduct hazard analyses, validate and verify preventive controls, and document corrective actions.
• Maintain audit-ready documentation for FDA, state, customer, and third-party audits.
• Manage controlled documents including SOPs, policies, forms, batch records, and training files.
• Issue, revise, archive, and track controlled documents in accordance with internal procedures.
• Ensure employee access to the most current versions of procedures and forms.
• Support internal audits, regulatory inspections, and customer visits.
• Collaborate with Production, QA, and Sanitation to ensure procedures reflect actual practices.
• Assist in training staff on updated documents, food safety programs, and regulatory requirements.
• Gathering, maintaining, and updating essential documents from vendors.
• Participate in continuous improvement initiatives related to quality and food safety.

Qualifications:

• PCQI certification required (or ability to obtain shortly after hire).
• Experience in food manufacturing, FDA-regulated industry, or similar environment preferred.
• Strong understanding of FSMA regulations and preventive controls requirements.
• Experience with document control systems (manual or electronic).
• Excellent attention to detail, organization, and communication skills.
• Ability to manage multiple projects and meet deadlines.
• Proficiency in Microsoft Office; experience with QMS or ERP systems is a plus.

Requirements

Qualifications:

PCQI certification required (or ability to obtain shortly after hire).

Experience in food manufacturing, FDA-regulated industry, or similar environment preferred.

Strong understanding of FSMA regulations and preventive controls requirements.

Experience with document control systems (manual or electronic).

Excellent attention to detail, organization, and communication skills.

Ability to manage multiple projects and meet deadlines.

Proficiency in Microsoft Office; experience with QMS or ERP systems is a plus.

Education & Qualification:

Bachelor’s Degree preferred.

2-4 years administrative experience.

Skills & Ability:

Demonstrated above average written communication skills in the English language.

Must be advanced with all MS Office software, must have excellent typing skills.

The ability to interact with department heads regarding corporate compliance.

Ability to maintain professional and positive attitude.

Ability to manage multiple tasks effectively & efficiently.

Possess high-level of ethics and integrity.

Must be able to keep information confidential.

Physical / Work Environment Requirements:

Ability to work in both office and production floor environments.

Ability to lift 25–40 lbs occasionally.

Ability to stand, walk, and observe production processes as needed.

Availability to support audits, recalls, and training sessions during off-hours if required.