Quality Control Analyst, Release Testing
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 Walkersville, MD has an exciting opportunity for a Quality Control Analyst – Release Testing. This successful candidate is responsible for performing routine and specialized analytical/compendia testing of raw materials, in-process materials, and finished goods. Test types performed include Sterility, Bioburden, Growth Promotion Qualification, Endotoxin, cell performance, chemistry, and biochemistry based testing of raw materials, intermediates, and finished goods. All testing is done in compliance with Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Maintaining the integrity of data generated is a critical aspect of the job. The individual is also responsible for working in a team atmosphere and meeting the needs of internal, as well as external, customers. The individual performs routine testing and project related tasks while being responsible for general lab support activities.
Primary Role Responsibilities:
- Schedules & performs routine and specialized testing of raw materials, intermediates and finished products according to Standard Operating Procedures and Test Methods in compliance with cGMP/GLP utilizing proper aseptic techniques (where applicable)
- 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.
- Serves as QC representative on project teams. May lead QC projects. Writes and revises Standard Operating Procedures and provides suggestions for method improvements. Provides advanced level training in addition to basic and specialized activities
- Writes OOS/deviation investigations and assists with technical investigations.
- Performs testing for total organic carbon (TOC), conductivity, nitrates, chlorine, hardness, and pH.
- Run analytical method transfer and qualification/validation experiments per approved protocols and with minimal guidance. Record, analyze, and review all data related to testing.
- Provides QC laboratory support on an as needed basis (to include, but not limited to sample receipt and stability activities). Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies. Maintain compliance with all required training.
- Perform other duties as assigned
Skill and/or Education Requirements:
- HS Diploma required; Bachelors degree in Scientific discipline preferred
- Proficient in the use of spreadsheets, databases, and word processing software.
- Computer software skills including Microsoft Office and SAP
- Able to propose ideas during problem solving, root cause analysis, and process improvement events.
- Identifies timelines for assigned tasks and proactively monitors progress.
- Able to prioritize own work.
- Strong written and oral communication
- Capable of effectively representing the department in meetings and on project teams. Provides timely, clear, and accurate updates without being prompted.
- Provides suggestions for improvement to documentation and workflows.
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.