Luitpold Pharmaceuticals, Inc.
Job Location
Shirley, NY
Job Description


Must be able to perform and assist Microbiologist II to perform the following: 
-antimicrobial preservative effectiveness testing. 
-annual validation of disinfectants. 
-container closure studies 
- thermal resistance studies 
- quality control qualification of biological indicators 
- bacterial endotoxin testing and bioburden testing on stoppers, vials and tubing 
- Edge of Failure Studies 
Maintain all necessary documentation regarding all activities listed above 
Perform validation of finished products and raw materials for bacterial endotoxin testing. 
Perform bacteriostasis and fungistasis studies for all finished products and raw materials. 
Undertake or oversee special projects, validation of new equipment and introduction of new tests or procedures in the laboratory. 
Assist in writing and perform all validation studies as required. Assist in writing final reports on data collected. 
Assist in performing investigations into out of specification or limits occurrences. 
Maintain all necessary documentation regarding all activities listed above. 
Train and provide technical assistance and guidance to microbiologists as necessary. 
Assist in review of data. 
Offer input/ suggestions for improvement in laboratory operations and procedures. 
Temporarily perform Group Leader’s duties to cover short absence...cont.

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