Quality Control Project Lead

Lonza Biologics Porriño SLU; Houston (TX); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Control Project Lead to make a significant impact in Houston. This pivotal role involves leading the introduction of new methods and processes in the QC department, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. If you have a strong background in quality control within a manufacturing environment and possess outstanding communication skills, this is an exciting opportunity to contribute to innovative projects that improve lives. Join a team where your expertise can help maintain world-class quality standards and drive success in the life sciences sector.

Qualifications

• Bachelor's degree or equivalent experience in Science or related field.
• Proven experience in a QC role within a manufacturing environment.

Responsibilities

• Lead introduction of new methods and processes into the QC department.
• Provide technical support during investigations and project teams.
• Ensure compliance with regulatory standards and internal policies.

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:

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

Key requirements:

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