Senior Quality Assurance Specialist

United States, Houston (Texas)

Today, Lonza is a global leader in life sciences operating across three 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.

Our Lonza site in Houston is seeking a Senior Quality Assurance Specialist (QA) Viral Vector (VV).  This individual  will represent the QA department on internal and external meetings ensuring that quality requirements are met. Support manufacturing operations and all support groups related to manufacturing execution.  Supports investigations using problem solving tools as owner or QA approver.  Supports execution and closure of corrective actions and change controls as owner or QA approver.  Review and QA approve GMP master documents and executed GMP documents from QC, manufacturing, material management, FE, and any other department that supports lot production.  Performs material and lot release.  Other duties include tracking quality records, participation in internal/external audits, QA on the floor execution, and overall cGMP compliance

Key responsibilities:

  • Perform the Quality Assurance review and approval of GMP documents including master documents, executed batch record documents, and quality systems records including but not limited to: change controls, deviations/ investigations, CAPAs and other controlled documents.
  • Provides QA support regarding aseptic fill activities such as media fills (aseptic process simulations), cell banking, and drug product filling operations.
  • Performs QA walkthroughs and works closely with manufacturing and support groups to resolve any issues identified during walkthroughs and performing QA release of suites as necessary.
  • Performs material and lot releases as applicable
  • Represents QA in internal and external meetings to ensure quality compliance
  • Support internal/external audits
  • Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.

Key requirements:

  • Bachelor’s Degree required in Life Sciences, Engineering or related field
  • Advanced industry experience within the biopharmaceutical field is required
  • cGMP environment experience and compliance.  Commercial GMP experience is preferred
  • GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred.
  • Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, TrackWise, Documentation, SAP and LIMS systems, preferred
  • Team player, with strong focus on safety, quality and timelines.
  • Work occurs in a fast-paced environment.  Individual must be able to prioritize own work. 

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.

Reference: R39481
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