Lead Batch Record Reviewer – GMP Compliance

Scorpion Therapeutics; Piscataway Township (NJ); On-site; USD 37,000 - 48,000; Full time

Benefits offered by this job

Short-term incentive opportunity

Job summary

Scorpion Therapeutics is seeking a Batch Record Reviewer Group Lead to oversee batch record reviews across manufacturing, packaging, and related operations in a pharmaceutical setting. You will ensure timely, accurate GMP-compliant documentation and coordinate with multiple departments to support execution and readiness.

The role requires 2+ years in Manufacturing or Packaging, strong knowledge of cGMP, leadership and communication skills, and proficiency with ERP/MES systems (JDE).

Qualifications

• High School diploma or GED required.
• 2+ years of experience in Manufacturing or Packaging.

Responsibilities

• Lead and perform detailed review of batch records for accuracy, completeness, and GMP compliance.
• Review work output for quality, consistency, and adherence to procedures.
• Serve as escalation point for complex documentation issues or cross-departmental concerns.
• Review and update manufacturing execution/ERP systems to ensure accurate batch status and documentation records.
• Coordinate issuance, control, and reconciliation of batch records, logbooks, labels, and controlled documents.
• Communicate documentation findings, trends, and improvement opportunities to supervisors and management.
• Collaborate with Manufacturing, Packaging, QA, Production Planning, and Supply Chain to support work order execution and documentation readiness.
• Identify recurring documentation errors and support CAPAs.
• Participate in process improvement initiatives to enhance documentation accuracy, efficiency, and compliance.

Skills

cGMP knowledge

Attention to detail

Leadership

Communication

Multi-tasking

ERP/MES (JDE)

Problem solving

Cross-functional collaboration

Education

High School diploma or GED

Tools

JDE ERP

Job description

Scorpion Therapeutics is seeking a Batch Record Reviewer Group Lead to oversee batch record reviews across manufacturing, packaging, and related operations in a pharmaceutical setting. You will ensure timely, accurate GMP-compliant documentation and coordinate with multiple departments to support execution and readiness.

The role requires 2+ years in Manufacturing or Packaging, strong knowledge of cGMP, leadership and communication skills, and proficiency with ERP/MES systems (JDE).