QA Associate

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

Purpose of the Position:

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

Key Focus Areas

  • 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

Education/ Experience

  • Bachelor’s Degree in Life Sciences or equivalent years of practical work experience required
  • 4-7 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
EOE  M/F/Disabled/VET