Senior Quality 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.

How You’ll Add Value…

This position is responsible for ensuring that GENEWIZ meets its business objectives through the effective implementation, management and auditing of the regulated services quality system.  The qualified candidate will contribute to quality management projects and to maintain laboratory compliance with FDA’s Good Laboratory Practices (GLP), Good Clinical Practice (GCP), CAP/CLIA, as well as State and Federal regulations

What You’ll Do…

  • Develop, maintain, review and communicate internal quality assurance guidelines, documents, standards and processes
  • Oversee and ensure compliance with organizational, state, federal and other laws and guidelines, identify gaps and ensure corrective actions are implemented
  • Lead internal audits of Quality System practices and programs
  • Maintain an effective employee training and documentation program
  • Work with Quality Assurance management in supporting customer or third-party audits
  • Assist with Standard Operating Procedure (SOP) writing and management including revision, tracking, updates and distribution
  • Develop and implement key process improvements to enhance Quality System and facilitate compliance

What you will Bring…

  • Bachelor’s Degree in Life Sciences or equivalent years of practical work experience required
  • Extensive years of experience in a GLP/cGMP environment required
  • Proficient in Microsoft Office, especially Excel
  • Strong verbal and written communication skills are essential
  • Detail oriented with strong organizational skills

Working Conditions/ Schedule

  • Home office based with occasional work onsite
  • Seldom travel (less than 10%)

EOE M/F/Disabled/VET