GMP Batch Records Lead — On-Site, 2nd Shift Expert

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

Benefits offered by this job

Strong benefits coverage

Generous PTO

Free Grüns

Well-being perks

Job summary

Grüns is seeking a Batch Record Review Lead for our Roanoke, TX facility. This on-site role supports production by owning and expediting batch records through QA release, ensuring GMP compliance and complete documentation.

The position spans multiple shifts with competitive hourly pay and a strong benefits package. The ideal candidate has 3+ years in batch record reviews within regulated manufacturing, is bilingual in English and Spanish, and is comfortable using ERP/WMS systems.

Qualifications

• 3+ years reviewing batch records or other controlled GMP documents in a regulated manufacturing setting, ideally supplements or food.
• Working knowledge of GMP, data integrity principles, and excellent documentation practices.
• Bilingual in English and Spanish.
• Comfortable in ERP and WMS systems (Fulfil.io is a plus).
• Accurate with yield, label, and component reconciliation math.
• Comfortable working on the production floor in required PPE.

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 elevate 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 knowledge

Data integrity

Documentation practices

Batch record reviews 3+ years

ERP/WMS familiarity

Yield reconciliation math

Tools

Fulfil.io

Job description

Grüns is seeking a Batch Record Review Lead for our Roanoke, TX facility. This on-site role supports production by owning and expediting batch records through QA release, ensuring GMP compliance and complete documentation.

The position spans multiple shifts with competitive hourly pay and a strong benefits package. The ideal candidate has 3+ years in batch record reviews within regulated manufacturing, is bilingual in English and Spanish, and is comfortable using ERP/WMS systems.