Quality Control Analyst - Raw Materials
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.
Responsible for evaluating and establishing appropriate testing of raw materials for compliance with applicable quality guidelines. Individual communicates and prepares sample shipments for contract laboratory testing. The individual also performs routine and specialized testing of raw materials and may also perform investigational testing or special experiments as instructed.
- Assist raw materials supervisor with identification of raw material testing requirements per applicable quality guidelines
- Performs sampling of raw materials per approved procedures and specifications.
- Performs routine and specialized raw material testing according to Standard Operating Procedures and Pharmacopeia methods, in compliance with cGMP.
- Communicates with subcontract labs to obtain information regarding capabilities, test timelines, and costs for testing unable to be performed in-house. Prepares sample shipments and submission paperwork for contract laboratory testing.
- Reviews raw material test data including subcontract testing
- Performs project related tasks as assigned
- Completes OOS/deviation investigations.
- Writes/revises Standard Operating Procedures (SOPs).
- Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies.
- Maintains compliance with all required training and assists with training of fellow analysts.
- Performs other duties as assigned.
- Bachelors Degree required, in scientific field preferred
- Experienced knowledge working in a scientific lab
- Experienced knowledge working in a cGMP environment
- Prior experience with raw material testing such as wet ID, spectroscopy, titration, pH, osmolality, and/or conductivity
- Knowledge of basic and specialized lab equipment.
- In-depth knowledge of cGMP principles. Able to identify breach of cGMP principles and provide suggested corrective actions.
- Considered Subject Matter Expert on routine and some specialized methods.
- Prior experience with SAP and TrackWise a plus
- Able to propose ideas during problem solving, root cause analysis, and process improvement events. Provides suggestions for improvement to documentation and workflows.
- Records test results and maintains raw data and accurate laboratory records.
- 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.
- Willing to pursue opportunities that can lead to substantial benefit, even if there are risks involved.
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.