QC Systems Specialist 1
HybridPortsmouth, England, United Kingdom
Job Summary
Manage and execute updates to QC chemical raw material specifications via compliance records, management requests, or change management channels. Build and maintain specification templates in Laboratory Information Management Systems (LIMS) and Document Management Systems (DMS). Collaborate with Raw Material Scientists and cross-functional stakeholders to develop accurate testing specifications while authoring standard operating procedures and work instructions. Apply strict Data Integrity principles aligned with Lonza DI policies and cGMP guidelines to ensure regulatory inspection readiness. This office-first role in Portsmouth, NH, offers 20% remote flexibility and a competitive hourly rate determined by qualifications. Join Lonza's global team manufacturing medicines of tomorrow.
Required Qualifications
- Minimum 2 years of editing, document control, or technical writing experience within a regulated cGMP environment
- Proficiency in Document Management Systems (DMS)
- Proficiency in Laboratory Information Management Systems (LIMS)
- Familiarity with change control practices
- Familiarity with pharmacopeial compendia (USP, EP)
- Advanced proficiency in Microsoft Office Suite (Word, Excel)
- Associate degree in a Science-related field
- Equivalent combination of education and years of relevant experience
Desired Qualifications
- biopharmaceutical/life sciences industry experience
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