Quality Assurance Batch Record Coordinator

Quality Assurance Batch Record Coordinator

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Pall Corporation, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve their toughest challenges. Our products serve diverse, global customer needs across a wide range of applications to advance health, safety and environmentally responsible technologies.

From airplane engines to hydraulic systems, scotch to smartphones, OLED screens to paper—everyday Pall is there, helping protect critical operating assets, improve product quality, minimize emissions and waste, and safeguard health. For the exponentially curious, Pall is a place where you can thrive and amplify your impact on the world. Find what drives you on a team with a more than 75-year history of discovery, determination, and innovation.

Learn about the Danaher Business System which makes everything possible.

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 role is based onsite in New Port Richey, FL and reports to the Quality Control Inspection Supervisor. The work schedule is Monday through Friday, 7:30 AM to 4:00 PM. The need to work a flexible schedule and overtime is routine.

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.

• Coordinate the receipt, organization, review, routing, storage, and retrieval of production batch records and related quality documentation.
• Review completed batch records, routers, inspection records, equipment logs, and supporting documentation for completeness, legibility, accuracy, required signatures, dates, and compliance with applicable procedures.
• Maintain accurate electronic and hard-copy filing systems using established naming conventions, retention requirements, and document control practices.

• High school diploma or equivalent required 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. 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, Master Control, 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.