Microbiologist I, Baxter

Microbiologist I

Baxter

Location:

United States of America, Jayuya

Category:

Research and Development

Contract Type:

Not provided

Salary:

Not provided

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Job Description:

Assist and perform the laboratory duties with the technical support and approval of the Quality Supervisor (Micro Lab). Perform Microbiology Laboratory equipment and methods qualifications, Investigations related to out of limit results, Sterilization studies, Trending Analysis, Quality Reports, and approve documentation as required. Ensure compliance with company SOP’s, specifications and company policies, 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, as requires microbiological test procedures and SOP's
Issue change control for new equipment and methods as applicable
Fill out monthly, quarterly and annual reports for the microbiological laboratory when its 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 (such as: spectrophotometer, microscope, Particle Counter, VITEK and others)
Provide training to laboratory personnel as required
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
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
Ability to write routine reports and correspondence
Fully bilingual (English and Spanish languages)
Ability to communicate, read, write and understand English/Spanish languages

What we offer:

Support for Parents
Continuing Education/Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Additional Information:

Job Posted:

March 20, 2025

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