QC Analyst 2 – 2nd Shift, Environmental Monitoring

Lonza, Inc. Houston, TX
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life. Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization? Job Description Summary Role Purpose Performs Environmental Monitoring of clean rooms in support of cell and gene therapy production. Maintain data and follow cGMP regulations including writing deviations and other Quality documentation. Skill set includes (but is not limited to) microbiology, total particulate counts, viable air and surface counts, and personnel monitoring during operations. Working hours are during 1st shift (day). Primary Accountabilities, Duties and Responsibilities Performs Environmental Monitoring of clean rooms in support of cell therapy production. Writes edits and approves Deviations (including EM Excursion reports). Responsible for initiating Change Controls and completing necessary documentation. Orders supplies, materials and reagents. Performs and plans general lab and equipment maintenance duties. Essential Job Functions Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Adhere to Good Documentation Practices. Maintenance of quality systems and cGMP compliance for the business by complying with processes, procedures and instructions for all activities in which the individual participates. A majority of the work is done in a laboratory and clean room environment. While working in the laboratory a lab coat is required along with appropriate safety equipment as denoted for the designated area. While working in the clean room the appropriate level of gowning is required, including sterile gowning. The remaining work is done in an office environment with use of a personal computer or meetings held in a conference room setting. Must be able to lift up to 30lbs Attention to detail is critical for this position. Minimum Required Qualifications/Skills Education BA or BS in a biomedical field Preferred area of study: Microbiology Experience 4+ years relevant experience in a biotech/pharmaceutical setting. OR, MS in related field and 2+ years relevant experience in a biotech/pharmaceutical setting. Knowledge Should have knowledge of cGMP facilities and cGMP requirements. Must have solid microbiology background and is aware of general clean room practices and sampling strategies. Must have an advanced knowledge of Microsoft applications, especially Word and Excel. Other computer software skills including SAP, Trackwise, Documentum, LIMS, and SysAid are a plus. Slills Must have good mathematics, scientific and good documentation skills. Knowledge of microbiology. Knowledge of cGMP (Biotech/Pharmaceutical industry). Knowledge of EM testing equipment including biosafety cabinets, laser particle counters, viable air monitoring equipment is required. Qualities & Attitude Must be detail-oriented and have a “right first-time” attitude. Must be able to clearly communicate problems and observations with management from other departments. Should work well in a team environment but have independent work skills and a strong work ethic. Able to clearly communicate problems and observations with management from other departments, and may be required to discuss technical issues directly with clients. Demonstrated skills in problem-solving and providing solutions. 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. Lonza. The place to Go, Stay and Grow.