Abbott Microbiologist in Alajuela, Costa Rica
Position Summary :
Supervise the microbiology function, providing direction consistent with the Cardiovascular Quality System. Applies microbiological concepts to the manufacturing process of a medical device and understands process monitoring/metrics to maintain microbiological quality of the final device. This position provides support to the sterilization processes, including but not limited to training and verification of sterilization runs.
Provides Facility Microbiological Support
Record review of routine microbiological test results
Routine release of manufactured product
Technical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods.
Handles routine out of specification test results, or more complex out of specification issues.
Data analysis of sterilization processes.
Participate in audits of sterilization, test lab, and biological product vendors.
Ensures correct documentation linkage flow for microbiologically related documents.
Writes new or updates current microbiologically related documents.
Maintains understanding of applicable standards and applies them to qualifications and test methods.
Writes protocols and reports for qualifications for sterilization and microbiological test methods.
Writes appropriate validation protocols; performs or oversees validations for new technologies, equipment, and/or test methods; creates documentation for implementation.
Develops sterilization cycles and laboratory test methods.
Works with technicians in conducting these qualifications.
Provides training to laboratory technicians on new equipment or new test procedures.
Provides training in the areas of sterilization validation and sterilization processes.
Authority to sign off Qualifications, DDAs, NCMRs, COs, FMEAs, PDP forms.
Degree in microbiology or related science.
Advance command of English.
Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
0-2 years of working experience on similar roles
Articulates microbiology technical concepts well.
Must have knowledge of Good Laboratory Practices (GLP's), Bacteriology and use of lab equipment such as Laminar Flow Hoods, as Autoclaves, Incubators, pH meter, analytical balance, etc.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com