Batch Record Quality & Compliance Reviewer

Nephron Pharmaceuticals Corporation; West Columbia (SC); On-site; USD 70,000 - 90,000; Full time

Job summary

Nephron Pharmaceuticals Corporation in West Columbia, SC seeks a Batch Record Review (BRR) professional to ensure manufacturing and packaging records meet cGMP and FDA requirements before release. You will review batch documentation, identify deviations, and drive corrective actions to prevent recalls, supporting QA and regulatory compliance across commercial, development, and engineering activities.

Strong attention to detail, written communication, and familiarity with GDP, SOPs, and document

Qualifications

• Knowledge of US FDA, cGMP, GCP, EMA, and ICH guidelines.
• Competent with MS Word and Excel.
• Adobe Acrobat advanced features and workflows.
• SharePoint document management familiarity.
• Excellent written and oral communication, teamwork.
• Ability to work independently with strong attention to detail.
• Technical writing skills and QA expertise.

Responsibilities

• Oversee status of batches through disposition and release processes.
• Perform final batch disposition to ensure compliant release of products.
• Review documentation for manufacturing activities with GDP compliance.
• Identify deviations and ensure corrective actions are taken.
• Support lot disposition and review test methods, validation protocols, and SOPs.
• Communicate quality risks to executive management in a timely manner.
• Archive batch documentation and revise SOPs to meet regulatory requirements.

Skills

cGMP knowledge

Quality Assurance

Technical writing

Microsoft Word/Excel

SharePoint

Education

BS degree in a scientific field

Tools

Adobe Acrobat

SharePoint

Job description

Nephron Pharmaceuticals Corporation in West Columbia, SC seeks a Batch Record Review (BRR) professional to ensure manufacturing and packaging records meet cGMP and FDA requirements before release. You will review batch documentation, identify deviations, and drive corrective actions to prevent recalls, supporting QA and regulatory compliance across commercial, development, and engineering activities.

Strong attention to detail, written communication, and familiarity with GDP, SOPs, and document