Quality Control Technical Specialist (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 Walkersville is IMMEDIATELY hiring a QC Technical Specialist to lead the introduction of new methods and processes into the Quality Control (QC) department via the technology transfer process. The QC Technical Specialist represents the department on project/product teams and provides technical support during investigations. And also enjoys bench work, endotoxin, bioburden, sterility and raw material testing.  

Key Accountabilities

• Provides QC representation to project/product team meetings. 
• Responsible for relaying pertinent information such as production schedules, testing status and information requests to applicable QC labs. 
• Supports stability program
• Supports implementation of site-wide/departmental projects and initiatives. 
• Develops, monitors, and reports metrics to assess the efficiency and success of technology transfer activities and tech services group projects.
• May perform general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies as needed to support lab(s).
• May aid supervisor with ensuring lab support activities are completed on time and properly.
• Participates in the initial assessment of new products and processes.  Provides input to program/product management regarding QC capabilities and requirements for method qualification/validation.  Reviews applicable regulatory guidance and internal policy documents to ensure compliance. 
• Writes, reviews, and/or approves SOPs, sampling plans, and QACS for new parts.
• Assists with responses to audits, deviations, out of specification (OOS) investigations, customer complaints, and corrective/preventative actions (CAPA). 
• 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 assay performance and responds to potential adverse trends.
• Leads technical investigations. 

Key Requirements

• Bachelor's Degree in Biology or related discipline required; Degree in Molecular Biology or Microbiology, preferred.
• 2 years of experience in cell-based assays using mammalian cells, cell maintenance and culture techniques required.
• Experience with method validation and technology transfer is a plus.
• Cell staining process experience is a plus.
• Knowledge of compendial microbiological and biological cell-based assays such as proliferation, cytochemical and immunofluorescence microscopy preferred.
• Proficient in the use of spreadsheets, databases, and word processing software.
• Must be able to perform statistical analysis of data.
• Knowledge of SAP and Track Wise systems is a plus.
• Must be able to write complex procedures and reports, communicate status, needs, forecasts, risks and timelines effectively to management.
• Must be able to identify and respond to complex problems, interpret complex data and draw valid conclusions.

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.