QA Batch Records Specialist – Documentation & Compliance

Danaher Corporation; Florida; On-site; USD 55,000 - 75,000; Full time

Job summary

Pall Corporation, a Danaher operating company, is seeking a Quality Assurance Batch Record Coordinator in New Port Richey, FL. The role supports manufacturing, quality and traceability by coordinating batch records and ensuring GDP and quality system compliance.

The position reports to the Quality Control Inspection Supervisor, with a Monday–Friday schedule from 7:30 AM to 4:00 PM and occasional overtime as needed.

Qualifications

• High school diploma or equivalent; minimum of 3 years in quality assurance, document control, batch record coordination, or regulated manufacturing environment.
• Strong understanding of quality management systems such as ISO 9001, AS9100, cGMP, GDP or similar; ability to support corrective actions and process improvements.
• Experience with ERP/Quality management/document control systems (SAP, MasterControl or similar).

Responsibilities

• Coordinate receipt, organization, review, routing, storage and retrieval of batch records and related quality documentation; track status and archival activities.
• Review batch records, routers, inspection records, equipment logs and supporting docs for completeness and compliance; resolve discrepancies with cross-functional teams.
• Maintain electronic and hard-copy filing systems with proper naming conventions and retention to support audits and product traceability.

Skills

Problem-solving skills

Computer literacy

Education

High school diploma

Tools

SAP

MasterControl

ERP

Job description

Pall Corporation, a Danaher operating company, is seeking a Quality Assurance Batch Record Coordinator in New Port Richey, FL. The role supports manufacturing, quality and traceability by coordinating batch records and ensuring GDP and quality system compliance.

The position reports to the Quality Control Inspection Supervisor, with a Monday–Friday schedule from 7:30 AM to 4:00 PM and occasional overtime as needed.