Laboratory Electronic Systems Analyst
Company: Coherus Biosciences
Posted on: November 24, 2022
Title: Laboratory Electronic Systems Analyst
Reports To: Vice President, Analytical Sciences
Location: Camarillo, CA
We are seeking a highly motivated individual to join the Coherus
Team as Electronic Laboratory Systems (ELS) 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) and/or Laboratory Execution System (LES),
Chromatography Data System (CDS) and other laboratory applications
following GxP regulations. The ELS 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. The ELS Analyst will further configure
and maintain functionality within laboratory software systems as
appropriate. Adhering to Coherus' change management procedures, the
Analyst will work closely with internal IT, QA, and external 3rd
parties to maintain current software versions and coordinate
* Implementation and configuration of LIMS, ELN, LES, 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
* Supports IT GxP team and vendors in creation and execution of
computer system validation documents (i.e. UAT, URS, OQ, PQ,
* 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 in
accordance with regulatory requirements.
* Establish procedures that effectively secure the laboratory
electronic systems and related applications and actively mitigates
potential security risks.
* Partner with IT Infrastructure team and 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.
* Other Duties & Responsibilities as assigned
* Experience in working with regulated (e.g., validated, 21CFR part
11 compliant), computerized systems.
* 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 preferred.
* Background in laboratory computing environment including
instrument and system interfaces and familiarity with laboratory
procedures preferred. Alternatively, experience in any regulated
environment, such as healthcare, will be considered.
* Experience with Thermo Sample Manager software preferred.
* Ability to explain technical details to non-technical
* 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 in real
* Excellent analytical and problem-solving skills
* Participate and support internal and agencies audits
Education and Experience:
* Bachelor's Degree in Computer Science, health-care related
degree, or other technical degree with required experience.
* Minimum 4 years' experience with regulated electronic systems and
software, ideally in a laboratory setting.
Beginning July 19, 2021, Coherus BioSciences requires all new hires
to be fully vaccinated against COVID-19 as of their start date.
This requirement is a condition of employment at Coherus
BioSciences, and it applies regardless of whether the position is
located at a Coherus BioSciences facility or is fully remote. If
you are unable to receive the vaccine due to a disability or
serious medical condition, or because it is prohibited as a result
of your sincerely held religious beliefs, you will have an
opportunity to request a reasonable accommodation.
Keywords: Coherus Biosciences, Camarillo , Laboratory Electronic Systems Analyst, Healthcare , Camarillo, California
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