Type of role: Hybrid - Onsite/Remote - Contract 12++ Months
Location: Camarillo, CA 93012
Our direct client is seeking a Laboratory Electronic Systems (LES) Analyst. This newly created role will report directly to the VP of Quality Laboratories and will be responsible for the configuration, implementation, administration, and maintenance of the laboratory electronic systems in a GxP environment. In this hands-on role, the incumbent will actively manage laboratory electronic systems including the Laboratory Information Management Systems (LIMS), Electronic Notebook (ELN), Chromatography Data System (CDS) and other laboratory applications following GxP regulations. The LES Analyst will work closely with stakeholders to identify and implement electronic solutions that support laboratory workflows including training and providing guidance of the lab staff. Adhering to clients' change management procedures, the Analyst will work closely with internal IT, QA, and external 3rd parties to maintain current software versions and coordinate upgrades.
*This can be a entry-level role for the right person wanting to gain more experience in the Lab Electronic Systems (LES) / Lab Instrument / QC areas.
Assist with Implementation of LIMS, ELN, CDS, and other laboratory applications compliant with GxP and applicable internal IT procedures.
Provide operations support to end users in the use of laboratory electronic systems while meeting GxP compliance requirements
Work closely with laboratory personnel, vendors, QA, and other IT professionals to assure systems are configured and maintained in a manner that addresses business needs, compliance to GxPs, and maximizes the system's efficiency and performance
Monitor performance health of the laboratory electronic systems and coordinates with vendors for any requirements for system maintenance.
Supports IT GxP team and vendors in creation and execution of computer system validation documents (i.e. UAT, URS, OQ, PQ, etc.)
Assist in the creation and maintenance of related SOPs.
Serve as technical point of contact for troubleshooting, addition of new instruments and/or workflows into the laboratory as well adding new end users.
Work closely with the laboratory leadership and project management teams to ensure the successful execution of projects
Ensure laboratory data are available, secure, and maintained
Establish procedures that effectively secure the laboratory electronic systems and related applications and actively mitigates potential security risks.
Partner with IT Infrastructure team/ external vendor to ensure the data and applications are protected according to the company’s disaster recovery policies.
Be onsite to install upgrades, new instruments/workflows, troubleshoot issues, and perform upgrades as needed.
Hands-on experience configuring and maintaining commercial GxP laboratory electronic platforms.
Working knowledge of GxP regulations as system administrator of laboratory electronic systems
Working knowledge in laboratory system testing, qualification, validation, problem resolution, and training
Background in laboratory computing environment including instrument and system interfaces and familiarity with laboratory procedures
Strong written and verbal communication skills across different and diverse groups or individuals
Ability to establish and maintain effective working relationships across the organization
Ability to work under pressure and troubleshoot problems
Excellent analytical and problem-solving skills
Ability to explain technical details to non-technical staff
Participate and support internal and agencies audits
Bachelor’s Degree in Computer Science, health-care related degree, or other