Batch Record QA & Compliance Specialist

Nephron Pharmaceuticals Corporation; Columbia (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

Nephron Pharmaceuticals Corporation in Columbia, SC seeks a Batch Record Review (BRR) professional to ensure manufacturing and packaging records meet cGMP and regulatory standards. You will verify completeness, accuracy, and adherence to GDP, driving timely batch disposition and product quality.

Responsibilities include reviewing batch records, mastering documentation, and supporting deviation management while collaborating across departments to sustain patient safety and regulatory compliance.

Qualifications

• Knowledge of US FDA, cGMP, GCP, EMA, ICH guidelines and compliant implementation.
• Proficient in MS Word and Excel; familiar with Adobe Acrobat workflows.
• Experience in document management and GDP compliance.
• Strong written and oral communication and cross-functional collaboration.
• Attention to detail with ability to meet QA deadlines.

Responsibilities

• Oversee batch disposition and release processes per cGMP requirements.
• Perform final batch disposition of finished drug products and ensure timely release.
• Review documentation for manufacturing activities including batch records and SOPs.
• Identify deviations and escalate quality risks to executive management.
• Support lot disposition and review test methods, method validation, and SOPs.
• Contribute to process improvements to meet QA deadlines.

Skills

Quality systems knowledge

Written & oral communication

Independent worker

Technical writing

Detail oriented

Time management

Team collaboration

Education

BS degree preferred in a related field

Tools

MS Word

MS Excel

Adobe Acrobat

SharePoint

Job description

Nephron Pharmaceuticals Corporation in Columbia, SC seeks a Batch Record Review (BRR) professional to ensure manufacturing and packaging records meet cGMP and regulatory standards. You will verify completeness, accuracy, and adherence to GDP, driving timely batch disposition and product quality.

Responsibilities include reviewing batch records, mastering documentation, and supporting deviation management while collaborating across departments to sustain patient safety and regulatory compliance.