Quality Assurance Batch Record Coordinator

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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact. Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 papereveryday 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. 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 its 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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the real-life impact of tomorrows 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 .

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- or .

Join our winning team today. Together well accelerate the real-life impact of tomorrows 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 .

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 please click 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- or .