Document Management Specialist

Location: South Plainfield, New Jersey, United States of America

Company Overview

At Azenta, formerly Brooks Life Sciences, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. 

Azenta Life Sciences is a global leader in the life sciences space with headquarters in Chelmsford, MA, and offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally.   We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally.

Summary

The Document Management Specialist will review all documentation housed within Qualtrax and provide guidance to authors for appropriate document type and structure.  Position will be responsible for record archival. Provide support for various documentation initiatives such as QMS (Quality Management System) integration/remediation. They will be expected to comply with, enforce, and be held accountable for all GxP regulations, other regulatory entities governing the company, and all job related procedures.

Essential Functions

Interact with all personnel levels and departments to help ensure full compliance with organizational, state, federal and other laws and guidelines as well as internal quality requirements. Reviews documentation submitted into Qualtrax for requirements outlined in the procedure. Provides guidance for documentation authors on appropriate document type and structure. Responsible for maintaining record archive. Complies with established communications code concerning Brooks Life Sciences business and patient confidential information. Works with area management on continuous improvement initiatives with the documentation management field. Performs some clerical duties. Monitor metrics related to documentation. Use available data to discern key quality information Provide support in customer/regulatory audit preparation and documentation Edit/create documentation within the QMS as needed.   Cooperates with Brooks Life Sciences staff to achieve goals. Performs other duties as directed.

Academic & Work Experience

Required:

  • Bachelor’s Degree in Life Sciences or equivalent years of related work experience required

  • 1+ years of experience in a GLP/cGMP environment required

Key Skills and Position Competencies

Required:

  • Ability to travel 10%

  • Proficient in Microsoft Office Suite.

  • Excellent interpersonal, organizational, oral, and written communication skills.

  • Strong attention to detail.

Preferred:

  • Quality Management System (QMS) experience.

  • Documentation hierarchy experience.

EOE  M/F/Disabled/VET