QC Raw Materials Analyst
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’s Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity the Cell Therapy.
The QC Raw Materials Analyst is responsible for coordinating and managing all outsource testing aspects for the Raw Materials Testing Group. Act as the primary contact coordinating all activities between Lonza raw materials lab and contract testing labs. Establish testing requirements and ensure testing turnaround times are met.
• Coordinates all outsource testing (i.e. development and routine release) for Raw Materials Group with minimal supervision.
• Drive purchase orders, submit testing requirements and ensuring proper billing to the appropriate contracts for accurate accounting of project charges.
• Point of contact for all contract test laboratories, with the ability to independently resolve minor issues (i.e. shipping and scheduling challenges) as well as recognize and immediately escalate Compliance risks to Management.
• Respond timely to excursions identified from out of specification results or invalid assays.
• Facilitates routine meetings with contract testing laboratories as the Lonza QC Raw Materials representative.
• Maintains accurate metrics regarding contract lab testing TAT’s, issues, etc. and proficient in the use of spreadsheets, databases, and word processing software to deliver thorough findings.
• Highly organized with ability to prioritize multiple changing priorities in a fast paced environment due to thinking, acting and responding quickly and professionally
• BS degree in Biochemistry, Chemistry or related Life Sciences
• Prior exposure working in an FDA regulated environment preferred
• In-depth knowledge of cGMP principles. Able to identify breach of cGMP principles and provide suggested corrective actions.
• Experience with Laboratory Investigations preferred.
• Prior experience with raw material testing such as wet ID, spectroscopy, titration, pH, osmolality, and/or conductivity
• Able to interpret USP & EP for testing and specification purposes
• Prior experience with SharePoint and DMS a plus
• Able to propose ideas during problem solving, root cause analysis, and process improvement events. Provides suggestions for improvement to documentation and workflows.
• Provides timely, clear, and accurate updates without being prompted.
• Dependable and able to work well within a team. Capable of effectively representing the department in meetings and on project teams
• Leads by example and offers guidance to co-workers with respect to compliance and personal interactions.
• Is optimistic and displays a positive attitude even during periods of adversity.
• Is often the first to volunteer for specialized tasks.
• Is considered a go-to person for assistance.
• Willing to pursue opportunities that can lead to substantial benefit, even if there are risks involved.
• Champions change speaking positively to and about others in all situations.
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.