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Assist and perform the laboratory duties with the technical support and approval of the Quality Supervisor. Ensure compliance with company SOP’s, FDA, GLP, and GMP regulations.
Job Responsibility:
Conduct microbiological analysis on raw materials, unsterilized and sterilized products, and analysis of controlled environmental areas and critical systems
Prepare and execute qualification protocols and final reports for Microbiology Laboratory equipment and methods qualifications
Generate, review and approve documentation in accordance with cGDP's and cGMP's and in compliance with corporate policies, specifications and standard operating procedures
Complete all testing, including special projects and protocol testing, in a timely and appropriate manner
Comply with the established milestones for each microbiological project as assigned by the immediate supervisor
Audit and update microbiological test procedures and SOP's as required
Issue change control for new equipment and methods as applicable
Fill out monthly, quarterly and annual reports for the microbiological laboratory when required
Perform investigations for out of limit or nonconformance situations
Assist the Department to comply with the established milestone for each microbiological procedure
Perform routine maintenance, trouble shooting and calibration of laboratory equipment related with the tests
Provide training to laboratory personnel as required
Keep the working area clean and organized
Perform review of test data, which includes overall documentation practices
Perform release functions in BLAS or BLIM system and Bacterial Endotoxin Test (BET)
Perform laboratory and production steam autoclave qualification studies
Requirements:
Bachelor’s degree in Science (preferably in Microbiology, Biology, Medical Technology or Biotechnology)
at least two years of previous experience
Fully bilingual (English and Spanish languages)
Nice to have:
Team worked oriented
ability to work at any shift when required
ability to work with many projects and handle multiple tasks at the same time
What we offer:
Medical and dental coverage starting on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan with company matching
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