BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Operations Technician to work for a leading San Diego biotechnology company.
This position is responsible for performing the tasks involved in the sampling and processing of client samples.
Performing environmental monitoring within QC laboratory, manufacturing suites, clean rooms, and fill/finish operations.
Perform microbiological testing at client sites including: viable air and surface, non-viable air, gram staining, colony counting and IDs.
Perform medical grade gas testing: viable, non-viable, hydrocarbons, dewpoint
Perform water testing: bioburden, total organic carbon assays, endotoxin, conductivity, pH
Perform microbiology tasks: media growth promotion, mold identification
Perform food microbiology: E. Coli, salmonella, listeria identifications
Experience in USP test methods, especially, USP , ,
Assist in the development of new procedures.
Assist in the implementation of new procedures and sampling equipment/methods.
Review data and test reports from internal and external testing for compliance to company and external compliance requirements.
Maintain controlled records of sampling and other collected data.
Receive orders against P.O.s, put stock.
Drafts and performs equipment and method validations.
Performs or coordinates a wide variety of microbiological or biological tests which are performed in accordance with approved protocols and summarizes the results in a final report or qualification.
Review reports completed by other Microbiologists or Laboratory Technician.
Assists in maintaining compliance to the Quality system and external regulatory bodies by keeping up-to-date on current regulations and industry standards and by ensuring testing and test method are compliant to the external and company standards.
Thorough knowledge in the concept, internal and external regulatory requirements in the following subjects: microbial environmental monitoring
Participate in the internal audits on department test methods and activities to confirm compliance and to identify improvement opportunity.
Strong knowledge of all microbiology routine test methods and schedules. Responsible for training new technicians and for test method validations. Will be able to lead problem- solving investigations in the event of test method failure for product failure
Minimum Qualifications (Education, Experience, Skills)
College degree preferred in area of biology, chemistry or related science.
Knowledge of good manufacturing practices (GMPs).
2-4 years relevant experience working in a QC laboratory or life sciences environment.
Excellent knowledge of Microsoft Word, Excel and PowerPoint
Adequate knowledge and understanding of industry-standards for sampling and inspections.
Excellent organizational skills.
Ability to communicate effectively orally and in writing.
Ability to foster a cooperative work environment.
Licensed California driver.
BioPhase Solutions - 14 months ago