Quality Control Project Lead

Lonza; Houston (TX); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Quality Control Project Lead to enhance quality control processes in Houston. This pivotal role involves leading the introduction of innovative methods and ensuring compliance with regulatory standards. You will collaborate with cross-functional teams, manage multiple projects, and contribute to maintaining world-class quality standards. Join a dynamic team dedicated to making a positive impact in life sciences, where your expertise will help drive meaningful change and improve lives globally. If you thrive in a challenging environment and are passionate about quality, this opportunity is for you.

Qualifications

• Proven experience in a QC role within a manufacturing environment.
• Strong technical knowledge to support investigations and tech transfer activities.

Responsibilities

• Lead the introduction of new methods into the QC department.
• Ensure compliance with regulatory and internal policy documents.
• Provide QC representation in project team meetings.

Skills

Quality Control

Technical Knowledge

Communication Skills

Project Management

Regulatory Compliance

Education

Bachelor’s degree in Science or related field

Job description

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.

Are you ready to lead a team and make a significant impact on the quality control processes at Lonza AG? We are looking for an exceptionally skilled Quality Control Project Lead to join our ambitious team in Houston, TX, USA. This role is pivotal in introducing new methods and processes into our QC department, ensuring we maintain our world-class standards. As a key player in our manufacturing operations, your work will help Lonza continue to grow and compete at the highest levels.

Key responsibilities:

• Lead the introduction of new methods and processes into the QC department via the technology transfer process.
• Represent the QC department on project teams and provide technical support during investigations.
• Participate in the initial assessment of new products and processes.
• Provide input to program management regarding QC capabilities and requirements for method qualification/validation.
• Ensure compliance with applicable regulatory mentorship and internal policy documents.
• Conduct technical reviews of Statements of Work (SOWs) to support contract manufacturing activities.
• Provide QC representation in project team meetings, relay pertinent information, and provide routine feedback.
• Support the stability program by gathering necessary information and tracking the status of timepoint summaries.
• Write, review, and/or approve Test Records/Forms, Sampling Plans, and Specifications.
• Lead tech transfer activities related to QC, including generation of master transfer plans, protocols, reports, training plans, and project timelines.
• Collaborate with BioAnalytical Services to craft qualification and validation protocols.
• Perform QC assessments of new raw materials and collaborate with SMEs to identify critical quality attributes and appropriate testing.
• Write, review, and approve raw material specification documents.
• Lead part number requests for QC materials required as part of assay transfer.
• Assist with responses to audits, deviations, OOS investigations, and CAPA.
• Perform other duties as assigned.

Key requirements:

• Bachelor’s degree or equivalent experience in Science or related field.
• Proven experience in a QC role within a manufacturing environment.
• Strong technical knowledge and ability to support investigations and tech transfer activities.
• Outstanding communication skills and ability to collaborate effectively with cross-functional teams.
• Experience in reviewing and approving technical documents and specifications.
• Knowledge of regulatory compliance and quality policies.
• Ability to manage multiple projects and priorities successfully.
• Diligent with a focus on achieving flawless results.

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.