QC Systems Lead - Empower Specialist

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 an experienced Quality Control Lead – Empower Specialist to join our phenomenal QC team. As our QC Lead- Empower Specialist, you will be responsible for day to day administration of the Laboratory Empower Chromatography Data System and Information System and maintain Data Integrity compliance per global procedures 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.

Key Responsibilities:

• 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.
• Empower project validation responsibilities includes verification of Instrument Method Settings, Integrity of Validated Custom Fields Calculations, and Report Method Settings.
• Assisting with administration of Empower and Chromeleon software. Involved in validation of new instrumentation associated with Empower and Chromeleon. Communicates with cross functional teams to interpret needs and priorities.
• Complies with GMP regulations with focus in data integrity. Performs activities required to mitigate any compliance gaps identified.
• 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.

Key Requirements:

• Bachelor or Master’s Degree. Preferred area of study in IT, Microbiology, Biochemistry, Chemistry or Related Science Fields.
• Minimum of 3-5 years of experience within a regulated cGMP industry.
• Experience working in Quality Control Laboratory or Enterprise computer systems.
• Experience with use of Enterprise GMP Quality Systems such as TrackWise, LIMS, iLAB, MODA, and Empower 3.
• Experience with Data Integrity and 21 CFR Part 11.
• 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).
• Power user experience in Empower is a plus.
• Ability to work and communicate in a team environment.

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.