Lab technician - united states, irvine

under limited supervision, culture and test bacterial spores for the biological

indicator manufacturing process in accordance with cgmp and sops.

conducts daily area clean up to maintain lab cleanliness in accordance to

established cgmp procedures

prepares and reviews batch records in accordance to cgdp.

performs preventative maintenance procedures and maintain laboratory

equipment in accordance to established standard operating procedures.

use and application of standard principles, theories, and concepts in the

field is required as well as the possible requirement of working knowledge

of other related disciplines to facilitate process corrections as directed by

supervisor.

expected to contribute and support experiments and the development of

methodologies.

provides basic developmental and technical support of both new and

existing products.

performs basic check to ensure quality products and data is produced in

adherence to applicable regulations.

assists in projects and participates on cross functional teams.

works on projects under the guidance of process leaders and project

facilitators.

assists in investigating and troubleshooting product deviations and

production issues using technical and scientific diagnostic methods as

directed by the supervisor.

assists in coordinating activities and maintaining detailed documentation of

development on projects and on teams in which this incumbent is a member.

 

basic qualifications:

4-year college degree (bachelor). knowledge of cgmp’s and cgdp’s.

basic laboratory knowledge and experience working in aseptic environment.

 

preferred qualifications:

area of study: biology, microbiology, or other related sciences. medical

device industry experience. knowledge of sap inventory management

system. experience working in a fda regulated environment. familiar with

fda regulations. experience in microscopy, gram staining, serial dilutions,

micro pipetting, ph testing, agar preparation, bacterial culture,

centrifugation.

equal opportunity employer/veterans/disabled



the company will consider qualified applicants with arrest and conviction records

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