Laboratory Manager - Microbiology
Intuitive Surgical, S. de R.L de C.V.
Mexicali, Baja California
Hace 2 horas
Productos médicos para cirugía.
Número de empleados
Sitio Web corporativo
Descripción y detalle de las actividades
The Laboratory Manager is responsible for organizing and managing the Microbiology Lab operations and that testing is performed in compliance with applicable regulations, company specifications, procedures, and policies and current industry practices. This position will establish, train and mentor a team that will support the operation of the Control Environmental Rooms (CER’s) at the Mexicali facility. Activities will include, but are not limited to oversight of routine environmental monitoring program, approval of environmental monitoring reports, investigation of quality events, development and management of corrective action / preventive action, support activities related to the construction of new CER’s.. The Laboratory Manager will report directly to the Site Director of Quality Operations and will collaborate with the group of subject matter experts (SME’s) in our corporate offices.
Experiencia y requisitos
• English Level: High (80-100%) • Bachelor’s degree in microbiology or similar discipline and 3-5 years of applied microbiology laboratory and environmental monitoring experience • Requires a relevant four-year degree with at least eight years of relevant experience in pharmaceutical environmental monitoring/microbiology • Knowledge of cGMP and regulatory compliance standards • Experience in performing trend analysis • Has in-depth working knowledge and understanding of microbial environmental monitoring and non-viable particulate monitoring • Experience with quality event investigation is required • Prior supervisory experience is highly preferred • Ability to multi-task and change priorities based on project criticality • Familiar with cleanroom microbiology and medical device sterilization • Knowledge of Statistical Techniques (e.g. Statistical Process Control (SPC)) • Knowledge of Minitab • Familiar with common EHS practices and procedures • Knowledge of SAP is a plus • Knowledge of Agile is a plus • Comfortable working in clean room environments
Número de vacantes 1
Jornada Tiempo Completo
Estudios Titulo Profesional