Quality Assurance Batch Record Coordinator

Danaher•New Port Richey, FL

4d•Onsite

About The Position

The Quality Assurance Batch Record Coordinator is responsible for coordinating, reviewing, tracking, maintaining, and archiving production and quality batch documentation to ensure records are complete, accurate, organized, and compliant with applicable quality system requirements, Good Documentation Practices (GDP), internal procedures, and customer requirements. This role supports manufacturing, quality, inspection readiness, product traceability, and timely documentation flow by ensuring batch records and supporting documents are properly controlled from completion through final disposition. This position requires access to export-controlled commodities, technical data, technology, software, and services. U.S. citizenship, U.S. legal permanent resident status, protected person status, or U.S. Government export authorization is required. Any offer of employment is contingent upon Pall obtaining the necessary employment visa and export authorization, including, if required, an export license from the applicable U.S. government agency.

Requirements

High school diploma or equivalent required
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.
Strong problem-solving skills and the ability to support corrective actions, process improvements, and documentation standardization.
Working knowledge of Good Documentation Practices, quality systems, controlled records, and documentation review expectations.
Experience working in a manufacturing, production, quality, pharmaceutical, medical device, aerospace, or similarly regulated environment preferred.
Experience with ERP, MRP, electronic quality management, document control, or record-keeping systems such as SAP, MasterControl, or similar platforms preferred.
Ability to sit and work at a computer for extended periods of time.
Ability to stand, walk, and move throughout production, quality, and records storage areas as needed.
Ability to read printed and electronic documentation, including detailed records, forms, labels, and reports.
Ability to lift, carry, or move record boxes or documentation materials up to 25 pounds occasionally.
Ability to use standard office equipment and perform repetitive hand and finger movements associated with computer and documentation work.
U.S. citizenship, U.S. legal permanent resident status, protected person status, or U.S. Government export authorization is required.

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 applicable procedures.
Verify that required documentation is present and aligned with approved work instructions, process requirements, quality system procedures, and customer or regulatory requirements.
Identify documentation errors, missing information, discrepancies, or potential compliance concerns and work with Manufacturing, Quality Assurance, Quality Control, Engineering, and other cross-functional teams to resolve issues.
Support batch record review activities associated with nonconformances, complaints, deviations, corrective actions, or quality investigations, as needed.
Maintain accurate electronic and hard-copy filing systems using established naming conventions, retention requirements, and document control practices.
Ensure records are stored in an organized, secure, and readily retrievable manner to support internal audits, customer audits, regulatory requests, investigations, and product traceability.