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Laboratory Electronic Systems Analyst

Company: Coherus Biosciences
Location: Camarillo
Posted on: November 24, 2022

Job Description:

Title: Laboratory Electronic Systems Analyst



Reports To: Vice President, Analytical Sciences



Location: Camarillo, CA



Classification: Non-Exempt



Overview:



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 upgrades.



Responsibilities:



* 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 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 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



Qualifications:



* 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 colleagues

* 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 time

* 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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