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$ 1800 to $ 2500 per month
November 17 2018
Execute routine microbial methods and testing in a GMP biopharmaceutical environment, including but not limited to bioburden, microbial limits, endotoxin, growth promotion, PCR, microbial identification and biological indicator testing, for samples which include but are not limited to raw materials, environmental monitoring, GMP utilities, in-process and final drug substance, validation samples.
Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples, as well as supporting shipment of samples to Amgen network sites and contract labs.
Support routine activities over the weekends and public holidays as scheduled.
Troubleshoot problems and participate in investigations if required.
Participate in equipment installation, commissioning and qualification, reagent and sample qualification.
Participate method transfers, method verification/qualification/validation and contract lab qualification
Participate in microbiology-related studies.
Revise documents and reports including but not limited to SOPs, JHA, technical reports.
Education / Licenses
Degree in Microbiology, Biology or related technological field.
0-3 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry.
Competencies / Skills
Knowledge and experience in GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods including aseptic laboratory techniques and monitoring of ISO Classified areas
Experience with Quality Control testing and laboratory operations for common microbiological testing methods and equipment; particularly focused on bioburden, endotoxin, environmental monitoring, viable sample plates’ interpretation.
Responsibilities will include data analysis and communication of results, writing protocols and performing assay transfer/validation and equipment qualification/verification as well as maintaining and operating specialized equipment.
GMP laboratory operation including conducting sample management and data management, Part 11 compliance
Good communication skills (technical writing and verbal communication/presentation)
Interact effectively and ability to work well in teams
Ability to manage multiple simultaneous activities in a rapidly changing environment