Batch Record Review Lead — GMP Compliance & Fast Release

Grüns

Roanoke (VA)

On-site

USD 30,000 - 33,000

Full time

4 days ago
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Benefits offered by this job

Comprehensive benefits package
Paid time off
Free Grüns

Job summary

Grüns is hiring on-site in Roanoke, TX for a Batch Record Review Lead. You will own the end-to-end review of batch records, ensuring completeness and GMP compliance, enabling QA release.

Expect to work across three shifts with an hourly rate and a strong emphasis on accuracy, data integrity, and timely reviews on the production floor. Ideal candidates have 3+ years in controlled GMP document review, fluent English/Spanish, and experience with ERP/WMS systems (Fulfil.io a plus).

Qualifications

  • Has 3+ years reviewing batch records or other controlled GMP documents in a regulated manufacturing setting, ideally supplements or food.
  • Has working knowledge of GMP, data integrity principles, and excellent documentation practices.
  • Is bilingual in English and Spanish.
  • Is comfortable in ERP and WMS systems (Fulfil.io is a plus).
  • Is accurate with yield, label, and component reconciliation math.
  • Is 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

Batch record review
GMP
Data integrity
Documentation practices
Bilingual English and Spanish

Tools

ERP system Fulfil.io
WMS systems

Job description

Grüns is hiring on-site in Roanoke, TX for a Batch Record Review Lead. You will own the end-to-end review of batch records, ensuring completeness and GMP compliance, enabling QA release.

Expect to work across three shifts with an hourly rate and a strong emphasis on accuracy, data integrity, and timely reviews on the production floor. Ideal candidates have 3+ years in controlled GMP document review, fluent English/Spanish, and experience with ERP/WMS systems (Fulfil.io a plus).

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