Quality Assurance Manager - Raw Materials

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.

Lonza Houston has an exciting opportunity for a Quality Assurance (QA) Manager – Raw Materials.  The QA Manager for Raw Materials will oversee the quality assurance team that supports the warehouse team, sampling/testing team, on the floor QA, material releases, material/part number creation and revision in SAP, vendor supplier qualification, and vendor change notifications.  They position also ensures QA support for internal and external project and team meetings.  The QA manager will also perform as owner or QA approver of deviations and change controls in Trackwise system.  Candidate will also support internal and external audits as required.  Commercial experience preferred but not required

Key responsibilities:

  • Manages the Quality Assurance Support – Raw Materials team that interacts directly with the Material Management/Warehouse, SAP part number, supplier qualification and sampling/testing teams at the site.
  • Oversees all aspects of QA Support – Raw Material operations within the facility, including but not limited to, material releases, on the floor QA support, SAP transactions, deviation investigations, change controls, vendor/supplier qualification, vendor change notifications (VCNs), creation and approval of new materials/part numbers in SAP, and master document revisions and approval (SOP, forms, material specifications, etc.).
  • Applies GMP knowledge to ensure that warehouse, sampling, vendor qualifications and vendor change notification processes comply with effective procedures and regulatory requirements.
  • Ensures QA support for internal and external project and team meetings.  Interfaces with customers and internal groups for resolution of quality issues.  Develops good working relationships with stakeholders and ensures appropriate and timely responses to client inquiries. 
  • Supports internal and external audits as needed.
  • Builds and maintains expertise in the QA Support – Raw Material team, including development of staff. 
  • Writes, revises, and/or approves quality, warehouse and sampling master documents (Ex. Standard Operating Procedures, forms, material specifications, etc.)
  • Reviews and approves executed documents (logbooks, forms, material specifications, etc.).
  • Manages deviations and change controls as owner or QA approver in Trackwise system

Key requirements:

  • Bachelors in Life Sciences
  • Advanced Quality Assurance industry experience within a cGMP environment is required
  • Prior experience with quality functions, aseptic techniques, GDP/GMP requirements, material release, investigation skills.
  • In-depth knowledge of cGMP principles.  Able to identify breach of cGMP principles and provide suggested corrective actions.
  • Able to propose ideas during problem solving, root cause analysis, and process improvement events
  • Provides suggestions for improvement to documentation and workflows. 
  • Dependable and able to work well within a team. Capable of effectively representing the department in meetings and on project teams
  • Prior experience with SAP, Trackwise and LIMS are a plus
  • Commercial experience preferred but not required

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: R33960