Quality Assurance Batch Record Coordinator

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

Bring more to life. 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.

In this role, you will have the opportunity to: 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.

The essential requirements of the job include: 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, MasterControl, or similar platforms preferred.

Travel, Motor Vehicle Record & Physical/Environment Requirements: 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.

Pall Corporation, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate...