This position performs various activities related to the inspection and testing of raw materials, in process, stability and finished product samples to ensure compliance with established specifications, procedures, policies and regulatory requirements.
Essential Job Functions –
Perform USP (USP 61, 62) limits testing.
Perform AET (USP 51 and EP 5.1.3) on stability, R&D and finished products
Performs Antimicrobial Assay testing as per USP 81.
Collect and test water samples for cleaning validation, TOC and other test
Perform suitability testing/method development for new products to include writing of protocols, execution and preparing final reports
Able to transfer micro method with a solid knowledge of USP 61 and 62.
Perform investigation to include out of specification results and deviations
Perform organism identification, EM monitoring and Water testing.
Write, review and revise SOP’s/STP’s as required
Preparing EM reports and Water reports on a monthly basis
Training of new Microbiologist and assist supervisor in the micro lab
Supervise the lab personnel’s in absence of microbiology supervisor
Performs all other duties as assigned.
Minimum Required Education, Experience & Skills
Bachelor’s Degree in Microbiology or related biology degree.
Minimum five to seven years in a Microbiology laboratory, 5 within a pharmaceutical regulated environment
Preferred Education, Experience & Skills
Knowledge of Microsoft Office to include Word, Excel, PowerPoint and Outlook
Experience in GMP/GLP environment
Ability to record and interpret Microbiology data, Solid aseptic technique, Familiarity with standard concepts, practices and procedures in the field of microbiology.
Physical & Mental Requirements: (check all that apply)
Ability to lift up to 50 pounds
Ability to push or pull heavy objects using up to 10 pounds of force
Ability to sit for extended periods of time
Ability to stand for extended periods of time
Ability to use fine motor skills to operate equipment and/or machinery
Ability to properly drive and/or operate a company vehicle
Ability to receive and comprehend instructions verbally and/or in writing
Ability to use logical reasoning for simple and complex problem solving