Lonza
QASpecialistIII
Neural analysis suggests this role is
optimal for Mid+ candidates.
“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
Full Job Description
**_QA Specialist III (3rd Shift, Monday-Thursday)_** **Location:** This is an on-site position located in Pearland, TX This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. **Shift:** Third Shift: Monday-Thursday 11p-8a. The purpose of this role is to support manufacturing operations and all support groups related to manufacturing execution. Supports investigations using problem solving tools. Supports corrective actions and change controls as needed. Review and approve GMP master documents and executed GMP documents from QC, manufacturing, material management, and any other department that supports lot production. Other duties include tracking quality records, QA on the floor execution, and overall cGMP compliance. **What you will get:** A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer: * Performance-related bonus. * Medical, dental and vision insurance. * 401(k) matching plan. * Life insurance, as well as short-term and long-term disability insurance. * Employee assistance programs. * Paid time off (PTO). Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge. **What you will do:** * Verify the company’s compliance with ISO/GMP quality system requirements and other regulatory guidance as appropriate. * Perform QA walkthroughs and work closely with manufacturing and support groups to resolve any issues identified during the walkthroughs. * Support activities that involve QA presence on the floor. * Review Master Batch Records (MBR) and supporting documents to support batch disposition. Perform review/release of Buffer/ media as needed. * Perform the Quality Assurance review and approval of GMP documents and Quality systems records. * Prioritize and manage a variety of projects simu
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