Audit-Ready QA: Batch Records Coordinator

Regulatory Jobs; Florida; Presencial; USD 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k)

Paid time off

Descripción de la vacante

Pall Corporation, a Danaher operating company, is seeking a Quality Assurance Batch Record Coordinator to coordinate and review production batch records and related quality documentation onsite in New Port Richey, FL. The role supports manufacturing, quality assurance, and audit readiness with a focus on GDP and controlled records.

The position requires a high school diploma and at least three years in quality-related roles, with familiarity with ERP/MRP systems and SAP/MasterControl preferred.

Formación

• High school diploma or equivalent and a minimum of three (3) years of experience in quality assurance, document control, batch record coordination, manufacturing documentation, inspection documentation, or a regulated manufacturing environment.
• Basic understanding of quality management systems such as ISO 9001, AS9100, cGMP, GDP, or similar regulated quality frameworks preferred.
• Working knowledge of Good Documentation Practices, quality systems, controlled records, and documentation review expectations; experience with ERP, MRP, electronic quality management, document control, or record-keeping systems such as SAP, MasterControl, or similar platforms preferred.

Responsabilidades

• Coordinate the receipt, organization, review, routing, storage, and retrieval of production batch records and related quality documentation; track status, issues, 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, accuracy, and compliance; resolve issues with cross-functional teams.
• Maintain accurate electronic and hard-copy filing systems using established conventions and retention requirements to support audits, regulatory requests, and product traceability.

Conocimientos

Batch records

Document control

Quality assurance

ERP

SAP

MasterControl

Educación

High school diploma

Herramientas

SAP

MasterControl

Descripción del empleo

Pall Corporation, a Danaher operating company, is seeking a Quality Assurance Batch Record Coordinator to coordinate and review production batch records and related quality documentation onsite in New Port Richey, FL. The role supports manufacturing, quality assurance, and audit readiness with a focus on GDP and controlled records.

The position requires a high school diploma and at least three years in quality-related roles, with familiarity with ERP/MRP systems and SAP/MasterControl preferred.