Batch Record Lead: GMP Compliance & Fast Release

gruns; Roanoke (TX); On-site; USD 30,000 - 33,000; Full time

Benefits offered by this job

Comprehensive benefits package

On-site role (Roanoke, TX)

Job summary

Grüns is seeking a Batch Record Review Lead for our Roanoke, TX facility to own the end-to-end review of every batch record on three shifts. This on-site role ensures records are complete, accurate, and GMP-compliant before QA release while production stays on the floor.

You’ll verify master records, lot numbers, yields, and components, reconcile data, and escalate deviations. The position requires 3+ years of GMP document review, strong data integrity, and bilingual English/Spanish skills, with

Qualifications

• 3+ years 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.

Responsibilities

• Own day-to-day review of every executed batch record, so Production Supervisors can stay on the floor.
• Check each record for completeness, accuracy, and GMP compliance before it goes to QA for review and release.
• Complete reviews within one day of submission, consistently.
• Verify master record version, lot numbers and quantities, equipment and cleaning entries, in-process checks, signatures, and dates.
• Reconcile yield, labels, and components with precision.
• Catch errors, omissions, and potential deviations early, and escalation to QA when a discrepancy is more than a simple correction.
• Run a closed-loop process for returning records, tracking corrections to completion, and escalating deviations.
• Track and report error trends, then work with Production and QA on the training and form changes that stop repeat errors.
• Work on the production floor in required PPE, building trust with operators and Supervisors

Skills

Bilingual English & Spanish

GMP documentation practices

Data integrity principles

ERP & WMS familiarity

Tools

Fulfil.io

Job description

Grüns is seeking a Batch Record Review Lead for our Roanoke, TX facility to own the end-to-end review of every batch record on three shifts. This on-site role ensures records are complete, accurate, and GMP-compliant before QA release while production stays on the floor.

You’ll verify master records, lot numbers, yields, and components, reconcile data, and escalate deviations. The position requires 3+ years of GMP document review, strong data integrity, and bilingual English/Spanish skills, with