Not specified; performance-related bonus available...
Onsite (monday to friday, 8:00 am – 5:00 pm est)
Bachelor's degree in life sciences or related field
Working knowledge of gmp regulations and guidelines
Experience with quality systems like dms, trackwise, sap, or syncade
The QA Compliance Specialist position at Lonza Group in Portsmouth, NH, focuses on ensuring compliance within the Cell Therapy Quality Management System (QMS). The role involves promoting regulatory adherence, supporting continuous improvement initiatives, and collaborating with cross-functional teams
Job Summary
This role supports the Cell Therapy Quality Management System by driving compliance and promoting inspection readiness.
The position involves independently reviewing controlled documents such as SOPs, work instructions, and validation protocols within a Document Management System.
Candidates will partner with subject matter experts to identify gaps in procedures and ensure adherence to regulatory requirements like Annex 1 and CFRs.
Matching Summary
Match Score: 85
The QA Compliance Specialist position at Lonza Group in Portsmouth, NH, focuses on ensuring compliance within the Cell Therapy Quality Management System (QMS). The role involves promoting regulatory adherence, supporting continuous improvement initiatives, and collaborating with cross-functional teams.
Salary
Not specified; Performance-related bonus available; Medical, dental, vision, 401(k) matching, life insurance, disability, PTO included
Skills & Requirements
Must-have
Bachelor's degree in Life Sciences or related field
Working knowledge of GMP regulations and guidelines
Experience with quality systems like DMS, TrackWise, SAP, or Syncade
Nice-to-have
Cell therapy or biologics experience
Strong cross-functional collaboration skills
Ability to drive continuous improvement initiatives
Key Requirements
Bachelor's degree in Life Sciences, Chemistry, or Biology