Sr. Technical Operations Associate I 8/19/2016
San Diego, CA
JOB DESCRIPTIONAPPLY Conducts the implementation of production procedures to optimize manufacturing processes and regulatory compliance. Assists with process transfer, process development, and product support activities that impact Laboratory Operations, Manufacturing, and Quality Control.
Collaborates with the Development group for the transfer of new laboratory assays to Laboratory Operations, Manufacturing, and Quality Control
Evaluates developmental processes for scalability and optimization in Manufacturing and Laboratory Operations
Participates in the assay verification and validation stages of the Design Control process
Provides product support for existing laboratory assays
Presents experimental data in group/department setting
Writes laboratory documents such as Manufacturing Batch Records and Standard Operating Procedures and departmental forms
Develops the Item Master Data (Bill of Materials, Bill of Operations, etc.) in Great Plains for new assays
Follows all appropriate safety procedures, policies and precautions
Position requires a Bachelor’s degree in the biological or life sciences with 5 to 8+ years of experience, or a Master’s degree with 2 to 5+ years of experience, in assay and product development, preferably in a diagnostic service and/or medical device industry. Experience transferring new assays following Design Control is strongly preferred. Experience working in a GLP/GMP/FDA/ISO9000 regulated environment and experience with immunoassays, molecular diagnostics, or laboratory automation strongly preferred.