United States, Greenwood (South Carolina)
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.
Responsible for the management and operation of the Microbiology Laboratory. Responsible for the testing and approval of raw materials and finished products, managing investigations and deviations, and communicating results to management. Responsible for ensuring compliance with company and compendial specifications, quality standards, and global regulations in support of the Hard Capsule (HC) and Dosage Forms Solution (DFS) businesses. Provides leadership, support and supervision to microbiology colleagues.
- Leads all activities associated with the daily operation of the Microbiology Laboratory; and on occasion, performs routine testing of raw materials and finished products.
- Reviews and maintains documentation and records for accuracy and compliance.
- Communicates with all levels of management regarding material release, product requirements, and ensures that materials meet regulatory requirements.
- Conducts professional dialog with internal and external customers, including complaint handling.
- Writes and updates Standard Operating Instructions, Policies, Protocols and Specifications.
- Reviews all SOI (Standard Operating Instructions) and WI(s) for the Microbiology Laboratory.
- Assists the lab with any microbiology issue such as compliance issues, questions and concerns. Also provides guidance to appropriate areas as it relates to Microbiology.
- Prepares facility & laboratory monthly Microbiology trending reports.
- Initiate & execute corrective actions based on trending results.
- Manages KPI (Key Performance Indicators) performance, goals and objectives.
- Issues and tracks necessary deviations, change control, MER (Material Evaluation Reports), and CAPA (corrective action/preventive action) related microbiology department.
- Reviews investigations dealing with finished product and raw materials out-of-specification results.
- Responsible for the evaluation, mentoring, coaching and development of laboratory colleagues.
- Reviews and approves microbiology investigations.
- Review laboratory documentation which includes CofA (Certificate of Analysis), logbooks/notebooks, media QC (Quality Control) sheets, environmental monitoring, etc.
- Supports and coordinates validation, special projects and other assignments related to microbiology department.
- Manages microbiology laboratory budget.
- Bachelor's Degree in Microbiology
- Experience with GMP manufacturing environment, ovens, incubators, autoclave, dishwasher, laminar-flow hood, and Vitek Identification System is preferred.
- Strong proficiency with word processing and spreadsheet software
- Strong and professional communication skills (written and verbal)
- Demonstrated proficiency with standard laboratory equipment
- Must be highly organized, detail oriented and able to manage multiple projects
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.