PCQI Documentation Specialist

Overview

Electrolit Manufacturing USA (EMUSA) is a new, state‑of‑the‑art beverage manufacturing facility in Waco, TX. The 640,000 sqft facility is situated in the Texas Central Industrial Park and will be operating on a 24/7 schedule. The facility will manufacture and distribute the 26 flavors of Electrolit™ – the fastest‑growing isotonic hydration beverage in the US.

Waco, TX – Onsite

The primary responsibility of the Document Control PCQI Specialist is to maintain and control quality and food safety documentation while supporting regulatory compliance for Low‑Acid Canned Food (LACF) beverage operations. This role ensures compliance with FDA regulations, including 21 CFR Parts 108, 113, and 117, and supports the development, maintenance, and implementation of the Food Safety Plan for shelf‑stable beverage products. The position will be working with sensitive information;

therefore, it will require an NDA. The Document Control PCQI Specialist will report to the Quality Manager of the Company.

• Create, review, revise, approve, distribute, and archive controlled documents such as forms, records, and food safety documents.
• Ensure current, approved documents are available at points of use.
• Manage electronic and/or manual document control systems.
• Support internal audits, customer audits, and regulatory inspections by organizing and providing requested documentation.
• Act as the designated Preventive Controls Qualified Individual (PCQI) for Low Acid Canned Food (LACF) beverage products.
• Ensure compliance with applicable FDA regulations, including: o a. 21 CFR Part 113 (LACF) b. 21 CFR Part 108 (Emergency Permit Control) c. 21 CFR Part 117 (FSMA Preventive Controls)
• Develop, implement, maintain, and reanalyze the Food Safety Plan with emphasis on: o a. Hazard analysis for self‑stable beverage processes b. Thermal processing and critical factor controls c. Container integrity and process monitoring
• Coordinate with approved Process Authorities to: o a. Support scheduled process development and validation b. Maintain approved scheduled processes for each product
• Manage and maintain LACF‑specific documentation, including: o a. FDA Food Canning Establishment (FCE) registrations and process filings (Form 2541) b. Scheduled process letters c. Thermal processing and critical factor records d. Container closure evaluations e. Deviation investigations and corrective action records
• Review food safety and production records to confirm compliance with scheduled processes.
• Evaluate and propose corrective actions related to process deviations, including product disposition when required.
• Assist the Primary quality/food safety contact during FDA inspections, state regulatory visits, and third‑party audits (e.g., SQF, BRCGS, FSSC 22000).
• Provide training and guidance to employees on LACF requirements, critical factors, and documentation expectations.
• Other duties as directed by Management.

Job performance will be assessed using measurable metrics, which may include but are not limited to:

• Production output and throughput targets.
• Accuracy and quality rates.
• Adherence to safety, regulatory, and compliance standards.
• Equipment uptime, utilization, and operational efficiency.
• On‑time completion and schedule adherence.
• Participation in and contribution to continuous improvement initiatives.

• Bachelor’s degree in Food Science, Microbiology, Quality, or related field required.
• PCQI certification required.
• LACF training or direct experience with FDA LACF requirements preferred.
• HACCP certification required.
• Strong knowledge of Microsoft Suite products required.
• Ability to use statistical software for basic data entry/analysis.
• Knowledge of security protocols and emergency preparedness.
• Knowledge of audits and regulatory inspections required.
• Knowledge of Company safety policies and applicable OSHA standards.
• One to three years (13) experience in a similar role within a beverage manufacturing environment required.
• Fluency in English is a must;
  Spanish a plus.

This position is primarily performed in an office environment during standard…