Research Laboratory Technician

CareAbout•Cypress, CA

7d•$19 - $26

About The Position

The Research Laboratory Technician provides supervisory functions relating to the Quality Assurance (QA) and Regulatory activities of the Clinical Safety Laboratory as well as the operational oversight of the cell isolation laboratory. This position provides operational oversight of the Clinical Safety Laboratory with regards to peer group data, inventory management, instrument preventative maintenance, reagent and instrument inventory, LIS set-up, and training

Requirements

Associates degree or higher in a field related to health science preferred.
Current BLS certification required.
2 years minimum experience in clinical research or equivalent by experience and training preferred
1+ years of Quality Assurance or Regulatory work experience preferred
Exhibits sound and accurate judgment and logical reasoning
Promote a positive, team-orientated, interaction between departments.
Positive role model; exhibits confidence in self and others.
Knowledge of the Microsoft Office Suite - A proficient user of Microsoft Office Applications including PowerPoint, Word, Excel, Outlook, Project.
Knowledge of other computer programs – SharePoint, LabDaq, Various Siemens instrument software.
Knowledge and use Multi-lined Call Center Tools. A proficient user of Call Center Customer Relations Management (CRM) tools, and ability to interpret reports and data from CRM.
bility to interpret and adjust quality control across multiple instrument platforms.
Possess an excellent understanding of the drug development process, clinical trial management, clinical monitoring, FDA regulations, and ICH Guidelines

Responsibilities

Provides day to day oversite of QA duties and personnel assigned to QA tasks
Maintains test activity menu with the College of American Pathologists
Files and has approved all assay validation
Works with clients to ensure correct laboratory report structure
Audits LIS system to ensure all reference ranges are up to date, interpretative tables are added where applicable, assays are categorized appropriately
Maintains Proficiency testing orders to ensure all active tests are enrolled in PT program
Input peer group data and adjust instrument QC ranges accordingly
Serve as secondary line instrument technical support
Design and implement sample requisitions for outside clients
Provide administrative support to Laboratory Operations Director, Technical Supervisor and Technical Consultant for any audits
Maintain active instrument test list
Follow established procedures for obtaining and processing biological specimens for analysis in the department
Each individual performs only those moderate complexity tests that are authorized by the Laboratory Operations Director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities
Learns operating and maintenance procedures for automated analytical equipment as assigned by the supervisor and in accordance with established protocol
Develops the ability to recognize factors and instrumental behavior that affects analytical measurements and result and takes appropriate corrective action in accordance with established protocols
Recognizes equipment malfunctions and failures and notifies the technologist and supervisor
Ensures the automated analytical results are accurately recorded on the designated worksheets and communicates the results to supervisory personnel for checking and verification.
Performs routine quality control procedures and records the results accurately on appropriate log sheets.
Recognizes out of control results and notifies supervisory personnel.
Assists in training new laboratory assistant and technician personnel by demonstrating necessary laboratory skills and procedures
Participates in continuing education programs as directed by the department technical supervisor
Follows appropriate safety practices in the laboratory at all times
Follows company guidelines and regulations
In the absence of the technical supervisor, the technician will report to the general supervisor or licensed technologists
Cell Isolation and Cryopreservation Laboratory Establishment (Contract negotiations, Logistics, Purchasing, Staff Training, Drafting and Implementing SOPs/WIs)
Proficient in multiple methods of isolation (CPT, Ficoll-Paque, Lymphoprep)
Staining and Counting Cells utilizing Guava ©, Cellometer©, and TC-20.(c)
Experience in aseptic techniques
Ability to educate clients on importance of isolation and how it applies to protocols.
Provide staff oversight
Educating staff on proper handling of LN2
Maintain and oversee reagents and consumable inventory of raw materials and products
SOP revision as it applies to study specific protocols
Instrument maintenance tracking
Adherence to GLP, GCP, GMP guidelines
Perform cryopreservation of all isolated cells.