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22 days old

Senior Lab Systems Analyst

Kelly Services
Arcadia, CA 91007
Kelly Science & Clinical is excited to be hiring a **_Senior Lab Systems Analyst_** for a leading Cell and Gene Therapy Manufacturing company in Arcadia, CA! The **_Sr. Lab Systems Analyst_** will play a key role in selection of vendors and systems, implementation, and maintenance of complex laboratory electronic systems. This role will lead in requirements gathering, user requirement specifications, configuration, solution design, design specifications writing, training, process improvement and support. Execute systems gap analysis, process mapping, road map creation to successful selection and implementation of new laboratory systems. Work with users extensively to identify solutions, provide user support for efficient and cost-effective operations to learn new technologies


**Job Duties Include:**


+ Serve as a project leader in the implementation Thermo Fisher SampleManager LIMS for QC, Manufacturing, and other areas as applicable.

+ Lead gathering of user requirements, configurations, design specification and communicate with developers to ensure proper development of the Laboratory systems and other electronic systems used in GMP manufacturing.

+ Describe workflow into software requirements, execute and review validation documents

+ Set up and organize system specific processes

+ Serve as the subject matter expert (SME) on validation requirement, master data setup, reporting, equipment integration, and enterprise systems related to QC and Manufacturing.

+ Ensure Laboratory system is compliant with all relevant regulatory standards and support audits for LIMS specific topics

+ Provide end user training to operate the system

+ Support training and use of LIMS and other lab systems for each functional area

+ Author, revise, implement, and manage LIMS and other lab systems related procedures for administrator and users

+ Create and maintain data configurations for users and integration of the instruments to LIMS

+ Partner with IT and external vendors to manage implementation, enhancements, incident investigation, system impact assessments and change controls

+ Lead, develop, and manage lab systems related change controls, NC, CAPAs

+ Implement best practices on LIMS development, master data, reporting, and configurations

+ Track and troubleshoot lab systems support program issues

+ Collaborate closely with IT group and stakeholders in developing system infrastructure and database requirements

+ Conduct risk assessments and champion continuous improvement


**Requirements:**


+ Bachelors degree in Life Sciences, Engineering or Computer Science

+ Minimum of 4 years of work experience with LIMS and other laboratory system in the Pharmaceutical, Life Sciences industry with cGMP, GLP. Experience with SampleManager preferred.

+ Experience with problem solving methods such as DMAIC or other similar Root Cause Analysis Tools

+ Familiarity with translating batch records, test methods and stability protocols into technical requirements and configuring in a LIMS solution

+ Experience in supporting sample plans, laboratory data and reports, data management and GxP compliance


**_Apply today to start a conversation on Whats Next for your Career!_**


+ Please feel free to schedule an interview directly with Athena to learn more: https://calendly.com/athp320/interview

+ Additional questions may also be e-mailed to athena.parker@kellyscientific.com.


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-12 Expires: 2022-10-13

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Senior Lab Systems Analyst

Kelly Services
Arcadia, CA 91007

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