Batch Record Review Lead

Grüns•Roanoke, TX

2d•Onsite

About The Position

The Batch Record Review Lead owns the end-to-end review process for executed batch records at Grüns’ Roanoke, Texas facility. The role ensures each record is complete, accurate, and GMP-compliant before it is submitted to QA for review and release, helping Production Supervisors remain focused on the production floor and preventing finished product from being delayed by review. The position reviews records within one day of submission, verifies key documentation and reconciles yields, labels, and components, and manages corrections and escalations through completion. It also tracks error trends and collaborates with Production and QA on training or form changes to prevent recurring issues. The role works on the production floor in required PPE and is fully on-site. Hiring is for Monday–Friday shifts: first shift, 6:00 a.m.–2:00 p.m. at $22 per hour; second shift, 2:00 p.m.–10:00 p.m. at $23 per hour; or third shift, 10:00 p.m.–6:00 a.m. at $24 per hour.

Requirements

At least 3 years of experience reviewing batch records or other controlled GMP documents in a regulated manufacturing setting.
Working knowledge of GMP, data integrity principles, and excellent documentation practices.
Bilingual in English and Spanish.
Comfort using ERP and WMS systems.
Accuracy with yield, label, and component reconciliation math.
Comfort working on the production floor in required PPE.

Nice To Haves

Experience in supplements or food manufacturing.
Experience with Fulfil.io.

Responsibilities

Own the day-to-day review of every executed batch record so Production Supervisors can remain focused on the production floor.
Check records for completeness, accuracy, and GMP compliance before they go to QA for review and release.
Complete reviews within one day of submission.
Verify master record version, lot numbers and quantities, equipment and cleaning entries, in-process checks, signatures, and dates.
Reconcile yield, labels, and components.
Identify errors, omissions, and potential deviations early, escalating discrepancies to QA when they require more than a simple correction.
Manage the closed-loop return process for records and track corrections through completion, escalating deviations as appropriate.
Track and report error trends and work with Production and QA on training and form changes to prevent repeat errors.
Work on the production floor in required PPE and build trust with operators and Supervisors.