Batch Record Review Lead — GMP Compliance

Grüns

United States

On-site

USD 30,000 - 33,000

Full time

9 days ago

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Benefits offered by this job

Generous PTO
Free Grüns product access

Job summary

Grüns is seeking a Batch Record Review Lead to own the end-to-end review of every batch record at our Roanoke, TX facility, ensuring completeness, accuracy, and GMP compliance on the production floor. You will oversee multiple shifts and work directly with production and QA teams to keep release timelines tight.

This on-site role requires 3+ years of GMP documentation experience, strong data integrity practices, and bilingual English/Spanish communication.

Qualifications

  • 3+ years reviewing batch records or GMP documents in a regulated manufacturing setting.
  • GMP and data integrity knowledge; excellent documentation practices.
  • Bilingual in English and Spanish.
  • Experience with ERP and WMS systems (Fulfil.io a plus).
  • Accurate with yield, labels, and component reconciliation.

Responsibilities

  • - Own day-to-day review of every batch record to free production floor time
  • - Verify records for completeness, accuracy, GMP compliance before QA
  • - Complete reviews within one day of submission
  • - Reconcile yield, labels and components with precision
  • - Escalate deviations to QA when necessary
  • - Work on the production floor in required PPE

Skills

Batch record review
GMP knowledge
Bilingual English/Spanish
ERP/WMS familiarity
Data reconciliation

Tools

Fulfil.io

Job description

Grüns is seeking a Batch Record Review Lead to own the end-to-end review of every batch record at our Roanoke, TX facility, ensuring completeness, accuracy, and GMP compliance on the production floor. You will oversee multiple shifts and work directly with production and QA teams to keep release timelines tight.

This on-site role requires 3+ years of GMP documentation experience, strong data integrity practices, and bilingual English/Spanish communication.

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