Abbott Microbiologist I in Sylmar, California
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
This position involves learning the application of microbiological concepts to the manufacturing process of a medical device and understanding process monitoring to maintain microbiological quality of the final device.
Provides Microbiological Support:
Record review of routine microbiological test results
Technical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods.
Conduct routine out of specification investigations. Perform data analysis of sterilization processes.
Develop and execute controlled access environment, deionized water and compressed air qualifications
Assess manufacturing process changes for microbial impact
Documentation o Ensures correct documentation linkage flow for microbiologically related documents.
Writes new or updates current microbiologically related documents.
Complete environmental disturbance reports
Complete LAL risk assessments
Complete annual controlled access environment reports
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.
Provides training to laboratory technicians on new equipment or new test procedures.
Provides training in the areas of sterilization validation and sterilization processes.
Other Projects as Directed by Department Manager.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Four-year degree in microbiology or related science, or a four-year degree and work in the field of microbiology.
Two to three years in a medical device, medical, pharmaceutical, food industry, or related industry (FDA controlled).
Two to three years in microbiology and/or sterilization
Person in this position demonstrates professional skills with excellent written communication.
Able to work with minimal supervision and ability to maintain regular and predictable attendance.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Medical & Scientific Affairs
ASJM Abbott St. Jude Medical
United States > Sylmar : 15900 Valley View Court
Yes, 5 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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