Senior Quality Assurance Specialist

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Houston is currently seeking a Senior Quality Assurance Specialist.

POSITION:                 Senior Quality Assurance Specialist

JOB LOCATION:      14905 Kirby Drive, Houston, TX 77047

DUTIES: Represent the QA Department on internal and external client meetings ensuring that quality requirements are met.  Support Manufacturing operations and all support groups related to manufacturing execution. Support Investigations using problem solving tools as owner or QA approver. Verify the company’s compliance with ISO/cGMP quality system requirements. Provide immediate support to operations and quality control staff to address compliance related concerns (QA “on-the-floor” support). Support execution and closure of deviations, corrective actions, and Change Controls as owner or QA approver. Perform review of Product Release Checklists. Perform release of batches. Act as a customer interface during on-site audits, conference calls and other standard means of communication. Review and QA approve GMP master documents and executed GMP documents from QC, Manufacturing, MSAT material management, FE and any other department that supports lot production. Serve as QA Subject Matter Expert for ViewLinc Trend review and approval for batch release. Manage projects from concept to completion: create and manage project plan, work cross functionally to ensure right first time and provide adequate training to impacted area. Interact with internal and external customers as a part of Jing and Internal Project Teams serving as the Quality Subject Matter Expert for any customer related quality issues. Support execution and closure of corrective actions and change controls as owner or QA approver. Utilize GMP Quality Assurance Compliance Systems (Document Compliance Manager, trackwise, Extranet SharePoint, SGG, LIMS) as well as 21CFR 210, 211, 820 and FDA Guidance on Aseptic Processing. Utilize Risk assessment tool (FMEA, FTA, Cause and Effect). Utilize Corrective and Preventative Actions (capas). Use TrackWise, DMS, SAP and LIMS system. Write highly Technical Documents (Manufacturing Batch Records, sops, Work Instructions, Protocols, Reports) and performing root cause analysis. Utilize Microsoft Office Suite (MS Excel, MS Word, MS Outlook, MS PowerPoint).  

MINIMUM REQUIREMENTS: Requires a Bachelor’s degree, or foreign equivalent degree, in Chemical Engineering or Pharmaceutical Science and five (5) years of progressive, post-baccalaureate experience in the job offered or five (5) years of progressive, post-baccalaureate experience in a related occupation utilizing GMP Quality Assurance Compliance Systems (Document Compliance Manager, TrackWise, Extranet SharePoint, SGG, LIMS) as well as 21CFR 210, 211, 820 and FDA Guidance on Aseptic Processing; utilizing Risk assessment tool (FMEA, FTA, Cause and Effect); utilizing Corrective and Preventative Actions (CAPAs); using TrackWise, DMS, SAP and LIMS system; writing highly technical documents (Manufacturing Batch Records, SOPs, Work Instructions, Protocols, Reports) and performing root cause analysis; and utilizing Microsoft Office Suite (MS Excel, MS Word, MS Outlook, MS PowerPoint).

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.