QA Batch Records Specialist: Documentation & Compliance

Radiometer; Town of Florida (NY); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

Benefits package

Job summary

Pall Corporation, a Danaher operating company, is seeking a Quality Assurance Batch Record Coordinator to coordinate, review, track, and archive production and quality batch documentation, ensuring records are complete, accurate, and compliant with GDP, ISO 9001, and related procedures. The role is onsite in New Port Richey, FL, with a Monday–Friday schedule.

You will support batch record review, corrections, approvals, and archival activities to enable on-time release and audit readiness,

Qualifications

• High school diploma or equivalent; minimum 3 years in QA/document control or regulated manufacturing.
• Basic understanding of ISO 9001, AS9100, cGMP, GDP, or similar frameworks.
• Experience with ERP/quality management systems and document control.
• Ability to coordinate batch records and support audits and investigations.

Responsibilities

• Coordinate receipt, organization, review, routing, storage, and retrieval of batch records.
• Track batch status, open documentation issues, corrections, approvals, and archival activities.
• Review completed batch records, routers, inspection records, equipment logs, and supporting documentation for completeness and compliance.
• Identify documentation errors and work with cross-functional teams to resolve issues.
• Maintain electronic and hard-copy filing systems per naming conventions and retention requirements.

Skills

Quality assurance

Document control

Batch records

Cross-functional collaboration

Education

High School Diploma

Tools

SAP

MasterControl

Job description

Pall Corporation, a Danaher operating company, is seeking a Quality Assurance Batch Record Coordinator to coordinate, review, track, and archive production and quality batch documentation, ensuring records are complete, accurate, and compliant with GDP, ISO 9001, and related procedures. The role is onsite in New Port Richey, FL, with a Monday–Friday schedule.

You will support batch record review, corrections, approvals, and archival activities to enable on-time release and audit readiness,