PIPELINE Quality Control - OQSIE
Fremont, CA
About the Job
BI Quality Control Pipeline
Similar to Req 7112094
Under supervision, performs testing, conducts lab investigations, problem-solves, and reports aberrant results tomanagement. Performs immunoassays, ELISA, and cell based assays. Work with mammalian cell culture, perform cell culture technique Ensures testing and release time lines are met. Follows well-defined and established procedures and best practices. Reviews QCtest results Documentation. Generates, reviews and/or maintains records or documents in a detailed and consistent manner. Prepares samplereconciliation reports and other reports as needed. Assists with QC's data management, including data review and controlcharting.
Process improvement and compliance: Coordinates and manages continuous improvement projects Revises standard operating procedures, trainingmanuals, etc which are submitted to management for review and final approval. Maintains specific QC files and databaserecords for process and/or quality improvement efforts. Manages and maintains deviation and change control records.
Skills: 3-5 years of industry expereince Experience in a GMP environment is strongly prefered Experience performing ELISA, cell culture and working with mammalian cell culture Very smart with a great attitude and a willingness to work hard with the team. Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and anability to interact with various departments and levels. Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able towork across functions to achieve common goals. Demonstrates strong attention to detail, and an ability to focus on details of execution. Demonstrates good facilitation, organizational and problem solving skills, as well as demonstrated
Education: Bachelors' degree in Biology or Life Sciences required
Similar to Req 7112094
Under supervision, performs testing, conducts lab investigations, problem-solves, and reports aberrant results tomanagement. Performs immunoassays, ELISA, and cell based assays. Work with mammalian cell culture, perform cell culture technique Ensures testing and release time lines are met. Follows well-defined and established procedures and best practices. Reviews QCtest results Documentation. Generates, reviews and/or maintains records or documents in a detailed and consistent manner. Prepares samplereconciliation reports and other reports as needed. Assists with QC's data management, including data review and controlcharting.
Process improvement and compliance: Coordinates and manages continuous improvement projects Revises standard operating procedures, trainingmanuals, etc which are submitted to management for review and final approval. Maintains specific QC files and databaserecords for process and/or quality improvement efforts. Manages and maintains deviation and change control records.
Skills: 3-5 years of industry expereince Experience in a GMP environment is strongly prefered Experience performing ELISA, cell culture and working with mammalian cell culture Very smart with a great attitude and a willingness to work hard with the team. Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and anability to interact with various departments and levels. Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able towork across functions to achieve common goals. Demonstrates strong attention to detail, and an ability to focus on details of execution. Demonstrates good facilitation, organizational and problem solving skills, as well as demonstrated
Education: Bachelors' degree in Biology or Life Sciences required
Source : OQSIE
