Quality Assurance: Batch Records Specialist

Pall Corporation; Town of Florida (NY); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

401(k)

Health insurance

Paid time off

Job summary

Pall Corporation seeks a dedicated Quality Assurance Batch Record Coordinator to coordinate, review, and archive production batch documentation, ensuring GDP and regulatory compliance. The role supports manufacturing, inspection readiness, and product traceability within a fast-paced environment.

You will work with cross-functional teams to resolve documentation issues, maintain organized files, and support audit readiness.

Qualifications

• High school diploma or equivalent and at least 3 years of experience in QA, document control, batch records, or a regulated manufacturing environment.
• Knowledge of ISO 9001, GDP, cGMP or similar frameworks; ability to support corrective actions and documentation standardization.
• Experience with ERP/MRP and electronic quality management systems such as SAP or MasterControl.

Responsibilities

• Coordinate the receipt, organization, review, routing, storage, and retrieval of production batch records and related quality documentation. Track batch record status, open documentation issues, corrections, approvals, and archival activities to support on-time release and audit readiness.
• Review completed batch records, routers, inspection records, equipment logs, and supporting documentation for completeness, legibility, accuracy, required signatures, dates, and compliance with procedures and customer/regulatory requirements.
• Maintain accurate electronic and hard-copy filing systems using established naming conventions and retention requirements to support internal and external audits and product traceability.

Skills

Batch record coordination

Quality assurance

Documentation control

Cross-functional collaboration

Education

High school diploma or equivalent

Tools

SAP

MasterControl

ERP systems

Job description

Pall Corporation seeks a dedicated Quality Assurance Batch Record Coordinator to coordinate, review, and archive production batch documentation, ensuring GDP and regulatory compliance. The role supports manufacturing, inspection readiness, and product traceability within a fast-paced environment.

You will work with cross-functional teams to resolve documentation issues, maintain organized files, and support audit readiness.