Quality Control Analyst- Raw Materials

United States, Walkersville (Maryland)

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 is actively seeking a Quality Control (QC) Analyst. This role is responsible for performing routine and specialized analytical/compendia testing of raw materials and sera, and water sampling and testing in compliance with Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).  Individual communicates and prepares sample shipments for contract laboratory testing. The role is responsible for working in a team atmosphere and meeting the needs of internal, as well as external, customers.

Key responsibilities:

  • Performs routine and specialized raw material testing, including IR/Raman spectroscopy and wet chemistry analysis 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.  Prepares sample shipments and submission paperwork for contract laboratory testing.  Reviews data received from contract lab for cGMP compliance.

  • Performs water sampling and conducts testing for total organic carbon (TOC), conductivity, nitrates, chlorine, hardness, and pH.

  • Performs other Quality Control testing as required (pH, Osmolality, Endotoxin Detection, etc.).

  • Records, analyzes, and reviews all data related to testing. Performs project related tasks as assigned with general instructions.  Writes OOS/deviation investigations with supervisor oversight.  Writes/revises Standard Operating Procedures (SOPs).  Trains other analysts on procedures, as needed.

  • 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.  Maintains compliance with all required training.

Key requirements:

  • A minimum of a Bachelor’s degree in a scientific discipline preferred (or equivalent experience accepted) preferred degree(s): Biology, Chemistry, Biochemistry.

  • Lab experience or vocational education in a field such as chemistry or biology and significant working experience.

  • Demonstrates a solid understanding of cGMP principles. Also able to identify breach of cGMP principles.

  • Acquires and documents training on all laboratory general tasks and is capable of performing assigned test methods and using associated instrumentation.

  • Demonstrates understanding of routine laboratory testing and principles behind methodology.

  • Understanding of basic laboratory equipment and aseptic technique a plus.

  • Proficient in the use of spreadsheets, databases, and word processing software.

  • Exercises judgment based on practice and precedence.

  • Able to prioritize work with input from supervisor. Makes good use of time.

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 in individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R33966
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