Lonza
QASpecialistIII
“QA Specialist III at Lonza. Skills: Quality Assurance, GMP, Document Review. Support manufacturing operations. Support investigations using problem solving tools”
Industry & Context.
Problem solving tools
Third Shift: Monday-Thursday 11p-8a
What They're Looking For.
Must Have
Bachelors in life sciences or engineering, or related field, GMP experience in the biologics and pharma industry, Working knowledge of equipment/facilities qualifications, GMP and GDP, Experience with regulations (US, EU, and other), Perform QA on the floor activities, Review batch records and QC TRF
What You'll Do.
Support manufacturing operations
Support investigations using problem solving tools
Support corrective actions and change controls
Review and approve GMP master documents
Review and approve executed GMP documents
Track quality records
Perform QA on the floor execution
Ensure cGMP compliance
Verify compliance with ISO/GMP quality system requirements
Verify compliance with other regulatory guidance
Perform QA walkthroughs
Resolve issues identified during walkthroughs
Support activities with QA presence on the floor
Review Master Batch Records
Review supporting documents for batch disposition
Perform review/release of Buffer/ media
Perform Quality Assurance review and approval of GMP documents
Perform Quality Assurance review and approval of Quality systems records
Prioritize and manage projects
Lead and direct work of others
How You'll Work.
Team & Collaboration
Work closely with manufacturing and support groups; Globally connected teams work together
Process & Methodology
Prioritize and manage a variety of projects simultaneously
Applying for this QA Specialist III role?
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