Quality Control Analyst Raw Materials (Biotech)

 

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 in Portsmouth, NH is searching for a Quality Control (QC) Analyst, Raw Materials Testing Lab to join our QC team. As our QC Analyst, you will be responsible for performing routine and specialized analytical/compendia testing of raw materials in compliance with Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). The individual is also responsible for working in a team atmosphere and meeting the needs of internal, as well as external customers. 

*The schedule for this position is Wednesday-Saturday 8AM- 6:30PM*

Key Responsibilities: 

• Performs routine and specialized raw material testing (including IR/Raman spectroscopy, wet chemistry analysis, titrations, HPLC and GC) according to Standard Operating Procedures and Pharmacopeia methods, in compliance with cGMP.
• Participates in method transfer/qualification/verification of test methods, new instruments, method qualifications
• May prepare sample shipments and submission paperwork for contract laboratory testing.  Reviews data received from contract lab for cGMP compliance in LIMS system.
• Records, analyzes, and reviews all data related to testing. Performs project related tasks as assigned with general instructions.
• Writes OOS (Out of Specification) /deviation investigations, change controls and CAPA.
• Writes/revises Standard Operating Procedures (SOPs), validation/qualification/verification protocols and reports for test methods.
• Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies. Maintains compliance with all required training.
• Trains other analysts.

Key Requirements: 

• Associates or Bachelors degree in Chemistry or Related Science Fields.
• Working experience within cGMP industry (preferred).

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.