Performs microbiological tests according to approved test methods SO P's and GMP's using required equipment.
This requires skills in the handling of microbiological laboratory equipment and materials and in the interpretation of data results.
Supports Cediprof and CMO business for all requested testing activities.
Functions:
Cultivates, isolates and performs microorganisms identification.
Performs Purified Water and Potable Water microbial analysis.
Performs microbial limit test of excipients, API, stability and finished products samples.
Prepares culture media according to current standard procedures.
Performs Culture Media Growth promotion and Sterility checks.
Perform laboratory areas and equipment cleaning as required in current procedures.
Keeps record of daily tests in the appropriate record books.
Performs daily calibration checks of all equipment in the laboratory using calibrated weights, standard buffers and calibrated thermometers.
Performs periodic checks of autoclave and incubators in the laboratory as per current procedures.
Performs sampling and/or testing for environmental monitoring program (Product Contact Surfaces, Swab, Ambient Air and Compressed Air) on microbiology laboratory, incoming, manufacturing and packaging areas following aseptic techniques and current procedure requirements.
Assists new Technologists training in laboratory tasks.
Performs method qualifications/validations as requires following current procedures.
Performs other duties as assigned.
Education Requirement:
Bachelor degree in Microbiology or Science.
Experience Requirement:
Two to four years of experience in the pharmaceutical industry.
Work Methodology:
100% On-site
6 months (1st Contract)
First Shift, Second Shift, or Mid Shift (Monday through Friday), based on business needs.
First Shift: Tuesday through Saturday or extended first shift may be required based on business needs.
Flexibility to work weekends and overtime as necessary.