Quality Control Specialist I (Biotech)
Today, Lonza is a global leader in life sciences operating across five 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.
The Quality Control Specialist I plays a critical role in ensuring the accuracy and reliability of testing within the Lonza Quality Control (QC) Laboratory. This position is responsible for performing a variety of laboratory functions while upholding the highest standards of quality and compliance. The Specialist will lead the introduction and implementation of new analytical methods and processes into the QC department through the established technology transfer process. Additionally, this role serves as a departmental representative on cross-functional project and product teams, contributing technical expertise and ensuring alignment with quality requirements. The Quality Control Specialist I also provides scientific and technical support during investigations, helping to identify root causes and implement effective corrective actions to maintain product quality and regulatory compliance.
Key Responsibilities:
Provides QC representation to project/product team meetings. Responsible for relaying pertinent information such as production schedules and information requests to applicable QC labs.
Provides routine feedback regarding tech transfer and testing status in a timely and accurate manner.
Supports stability program by gathering information needed to initiate protocols and tracks status of timepoint summaries.
Supports implementation of site-wide/departmental projects and initiatives, to include APS, Cleaning Validations and gown validations.
Develops, monitors, and reports metrics as needed.
Reviews, analyzes, interprets, and reports data following GDP and ALCOA+ principles in a timely fashion.
May perform general lab support activities such as Environmental and Utility sampling, testing, housekeeping, equipment maintenance, inventory/ordering of supplies as needed to support lab(s). May aid supervisor by ensuring lab support activities are completed on time and properly.
Assists with the initial assessment of new products and processes.
Works in cooperation with MSAT teams to design assay transfer, qualification, and validation protocols. May participate in the execution of such protocols and may perform routine or specialized testing as needed to support lab(s).
Assists with QC procurement, setup, and validation activities for new equipment required to support new methodology.
Monitors environmental and assay performance and responds to potential adverse trends.
Assists with technical investigations.
Assists with responses to audits, deviations, out of specification (OOS) investigations, customer complaints, Change Controls, and
corrective/preventative actions (CAPA) as needed.
Writes, reviews, and/or approves SOPs, MODA plan changes, sampling plans, and QACS for new parts; may perform EM and Utility data review as well as trend reports and microorganism profile assessments.
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.
Perform other duties as assigned.
Key Requirements:
M.S. / B.S. in Life Sciences with emphasis in cell biology, molecular biology, microbiology, or biochemistry.
Proficiency with cell-based assays, media preparation, and cell banking.
Knowledge of analytical instrumentation such as HPLC/UPLC, TOC Analyzer, Karl Fischer Titration, and pH/Osmolality/Conductivity meters, preferred.
Experience with method validation and technology transfer required.
Able to develop and deliver training programs for specialized and advanced activities. Trains trainers on how to develop effective on the job training.
Uses experience and knowledge to solve problems, make decisions, and develop plans for the group. Makes recommendations for the department.
Able to write complex procedures and reports.
Demonstrated experience in management of complex tasks and projects.
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.
The full-time base annual salary for this On-site position is expected to range between $69,000.00 and $111,000.00. Compensation for the role will depend on a number of factors, including the successful candidate's qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
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.
