Vacancy caducado!
Esoterix is a medical testing laboratory located in a suburban area of Calabasas Hills. The lab specializes in testing for endocrinology disorders with an expertise in pediatric testing. The R&D department provides technical leadership and expertise in bringing cutting edge technologies in assay development and automation to diagnostic laboratory services.Essential Job Duties:
Working with minimal supervision, oversees the process improvement activities and the technical aspects of reagent preparation related to optimization, raw material inventory, stability, troubleshooting, validation, scale-up and automation for reagent manufacturing. This includes working with isotopic reagents.
Provide oversight in ensuring that reagents are manufactured using robust processes so that the reagent inventory system is maintained optimally.
Develop and improve manufacturing processes and methods focusing on quality, efficiency and cost reduction. Collaborates with appropriate individuals in the laboratory and internal departments (R&D, QA, QC, operational teams) to identify trends, solve issues, troubleshoot and modify processes to prevent recurrence of problems.
Receives and logs in raw materials and reagents. Maintains inventory of critical raw materials, sources replacement/alternative materials and organizes feasibility and validation testing.
Analyzes and reviews data according to established guidelines. Communicates reagent status, data, reports, effectively addressing any issues that may arise.
Track the approval of respective data packages and notify key management of delays.
Performs all technical procedures in support of improvement in analysis, QC, manufacturing and release of componentry and product in accordance with the GLP and GMP guidelines established.
Supervise and train staff on new processes.
Writes and reviews batch records, SOPs, validation plans, validation reports and materials for management review.
Set-up, utilize, and maintain complex instrumentation.
Adheres to the standard operating procedures and safety requirements of Esoterix, CLIA, CAP and other regulatory bodies.
Documents all activities as necessary including preventative maintenance logs, instrument function checks, troubleshooting, and quality control to ensure regulatory compliance.
Follows any other job-related instructions and performs any other job related duties requested by department management.
RequirementsJob Requirements:
Master's Degree or BS with a minimum of 5 years experience in the lab.
Significant laboratory or related industry experience with reagent manufacturing, assay development or research experience.
Excellent communication, organizational, and teamwork skills. Ability to handle multiple projects simultaneously.
Fluency in Microsoft Office applications (Word, Excel, Powerpoint, Outlook, etc).
Shift1Schedule1st Shift (M-F 8am-430p)As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
Vacancy caducado!