Sr. QC Lead - LIMS/Empower Administrator
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 an experienced Quality Control Lead – LIMS/Empower Administrator to join our phenomenal QC team. As our QC Lead- LIMS/Empower Administrator, you will be responsible for day to day administration of the Laboratory Empower Chromatography Data System and Information System at the Portsmouth NH Site. Additionally, this position may administer other laboratory computer systems and support other teams in the QC Operations team such as Stability, Sample Management, Technology Transfer, Computer System Validation of analytical instruments and software.
- Ensures regulatory requirements and Lonza policies pertaining to analytical instruments and computer software applications are met. Completes QC analytical instrument and software validation deliverables, writes GMP procedures, validation documents and executes test scripts. Approves final project documents and writes final validation summary reports.
- LIMS administration responsibilities include conversion of test methods, batch records and other written source documents into analyses and templates in the LIMS system.
- Empower project validation responsibilities includes verification of Instrument Method Settings, Method Set Settings, Sample Set Method Settings, Integrity of Validated Custom Fields Calculations, Processing Method Settings, and Report Method Settings.
- Leads team and performs technical, root-cause analysis for complex system issues or errors and completes recommended solutions. Performs user and application software administration on Enterprise systems. Works on troubleshooting assignments that are complex in nature where considerable judgment and initiative are required in making creative and effective recommendations to solve problems. Completes system audit trail reviews, monitors back-ups and performs validation maintenance on systems.
- Recommends and implements analytical instrument and software engineering controls for QC Laboratories. Ensures data integrity IT/OT security by configuring computer OS and application security policies, file/folder permissions, data back-up scheduler, instrument parameters and method templates. May be ACSV SME during regulatory and customer Inspections and Audits.
- Performs all aspects of QMS process’ – Change Control, Deviations, CAPAs, Tasks Writes, reviews, assesses, and/or approves change controls for analytical instruments and software used in QC laboratories and manufacturing.
- Bachelor or Master’s Degree. Preferred area of study in IT, Microbiology, Biochemistry, Chemistry or Related Science Fields.
- Experience within a regulated cGMP industry.
- Significant experience working in Quality Control Laboratory or Enterprise computer systems.
- Significant experience with use of Enterprise GMP Quality Systems such as TrackWise, LIMS, iLAB, MODA, and Empower 3.
- Significant Experience in Analytical Laboratory testing (ie: protein purification and characterization, protein chromatography, SDS-PAGE, Western blotting, and amino acid analysis, TOC, Bioburden, Endotoxin, Elisa, Flow cytometry).
- Project management experience to independently drive projects to on-time completion.
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.