Responsible for testing procedures in RSE/CSE testing, contract Testing and associated support functions related to daily operations of the Technical Service Department.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Perform RSE/CSE ratio determination/analysis and maintain appropriate records for use in final report/protocol.
Perform routine contract testing for customers.
Assist with LAL testing as needed for special studies as assigned encompassing a full range of LAL techniques, gel-clot, kinetic, endpoint and PTS.
Responsible for performing IQ,OQ,PQ of equipment such as Tecan, Biotek, PTS and maintains appropriate documents.
Responsible for preparing and stocking supplies associated with duties.
Responsible for proficiency in all SOPs in areas of responsibility.
Responsible for documentation as required by company policy, cGMP and FDA.
Responsible for proper cleaning and maintenance of the Technical Service laboratory and associated equipment and adherence to established safety procedures.
Performs seasonal duties associated with processing crude LAL.
Associates degree in chemistry, microbiology, biology, or MLT Medical Lab Technology and 3 years related experience.
Advanced computer and math literacy required.
Specific in-house training will be provided and maintained on the employee training record.
Some travel may be required.