QA Batch Records Specialist (cGMP)

NEPHRON SC, LLC; West Columbia (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

NEPHRON SC, LLC is seeking an experienced Batch Record Review specialist to ensure manufacturing and packaging records comply with cGMP and regulatory standards. You will verify documentation, identify deviations, and support timely product release.

This role requires meticulous attention to detail, strong technical writing, and the ability to collaborate with QA, manufacturing, and engineering to uphold product quality and patient safety. Prior pharma GMP experience preferred.

Qualifications

• Knowledge of US FDA, cGMP, GCP, EMA, and ICH guidelines.
• Proficient in Microsoft Word and Excel.
• Familiar with SharePoint and PDF workflows.
• Excellent written and oral communication skills.
• Strong attention to detail and crossfunctional collaboration.
• Able to work independently and manage multiple resources.

Responsibilities

• Oversee status of batches through disposition/release process.
• Perform final batch disposition of finished drug product to ensure timely release within metrics.
• Review documentation for manufacturing activities per GDP.
• Identify deviations and ensure corrective actions.
• Communicate quality risks to Executive Management.
• Support evaluation and lot disposition of drug product.
• Contribute to process improvements to meet QA deadlines.
• Review cGMP documentation against SOPs.

Skills

Quality systems

cGMP knowledge

FDA compliance

GCP

EMA/ICH

Microsoft Word

Microsoft Excel

Adobe Acrobat

SharePoint

Technical writing

Attention to detail

Team collaboration

Communication skills

Education

BS degree preferred

GDP experience

Tools

SharePoint

Microsoft Word

Microsoft Excel

Adobe Acrobat

Job description

NEPHRON SC, LLC is seeking an experienced Batch Record Review specialist to ensure manufacturing and packaging records comply with cGMP and regulatory standards. You will verify documentation, identify deviations, and support timely product release.

This role requires meticulous attention to detail, strong technical writing, and the ability to collaborate with QA, manufacturing, and engineering to uphold product quality and patient safety. Prior pharma GMP experience preferred.