Lab Operations Specialist - III

Company: Intelliswift Software Inc
Location: Santa Monica
Posted on: September 18, 2022

Job Description:

This position will be responsible for maintaining a Laboratory Information Management System (LIMS) and Electronic Laboratory Notebook (ELN) for Clinical Biospecimen Testing laboratories from a business perspective. To include: constructing and performing routine maintenance on LIMS templates, reports, workflows, etc. Troubleshoot application problems to minimize error potential and streamline laboratory workflow. Perform integration and acceptance testing on LIMS changes to ensure proper performance before general release. Provide timely response to user needs to include managing user accounts, troubleshooting applications, updating or creating new report templates (hardcopy and electronic), and maintaining change records in accordance with version control procedures. The Business LIMS Administrator will also document new user requirements as the system matures for new LIMS functionality and provide support to the LIMS development effort provided by system analysts and system engineers. Responsibilities may include taking the lead as a lab proxy to ensure new functionality meets user requirements, writing acceptance test scripts for new LIMS functionality, and participating in the validation of new software releases.

This position will also have the opportunity to aid with in-depth analysis and interpretation of industry regulatory standards and standard practices related to laboratory analytical systems and clinical and pre-clinical manufacturing systems implementations. This position will be expected to coordinate and/or conduct reviews of the recommended practices and operating procedures for these systems. The position will require knowledge of computerized systems architecture including network infrastructure, hardware and software support, applications development, and database technologies. The candidate will be expected to be aware of advances in the various scientific and scientific computing fields, either by additional formal training, attendance to scientific gatherings or workshops, as required. Familiarity with regulatory guidelines (21 CFR part 11, in particular) is a major plus. This position will require constant collaborative interactions with co-workers across functional groups and Departments. Strong interpersonal skills, outstanding verbal and written communication skills are essential. This position will directly interface with members of Enterprise Information Technology, Validation, Clinical Development, Quality, Discovery Research, Clinical Pharmacology, and others as needed.

Requirements/Qualifications:

Qualified candidates should have a 4 year technical degree relating to science, such as Chemistry, Biology, or Computer Science. Strong computer skills with the demonstrated ability to understand a variety of systems development concepts and applications. 4-6 years related experience is desired. Experience in designing and conducting system validations, along with strong familiarity of lab instrumentation/processes, and project management are preferred. Experience with (LIMS) Laboratory Information Management Systems, (ELN) Electronic Lab Notebook, Request & Inventory Systems, Data Warehouse Systems, is a must.

Education: B.S./M.S in Chemistry, Biochemistry, Information Technologies, Biology or related field.

Experience: 4-6 years of laboratory/IT experience with Bachelors or 3 years experience with a Masters degree (preferably in a GLP/GCP/GMP environment).

Special Skills/Abilities: The candidate must possess broad knowledge of methods and protocols typical of a GMP/GCP/GLP laboratory, as well as familiarity with computer science or information technology. Experience with Pharmacokinetics, Pharmacodynamics, and Flow Cytometry analysis, molecular biology, cell line engineering, and protein sciences is a strong asset. Good verbal and written communication skills are required. Candidate must possess good time management skills and organizational skills.

Keywords: Intelliswift Software Inc, Santa Monica , Lab Operations Specialist - III, Healthcare , Santa Monica, California