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1+ months

Sr. LIMS Administrator

Kelly Services
Arcadia, CA 91007
**Kelly Services is actively recruiting for a Sr. LIMS Administrator for a Direct Hire opportunity in Greater Pasadena area, CA.**


Position Summary:


The QC LIMS Administrator has a unique opportunity to play a key role in development, configuration, validation, implementation and maintenance of the QC LIMS system and processes from ground up for a Cell and Gene therapy biotech startup. This role is a main point of contact for LIMS implementation and work in conjunction with Validation on the execution of testing scripts for IQ, OQ and PQ of implementation of new LIMS System. The QC LIMS Administrator will be responsible for leading and managing activities for LIMS system as it relates to various QC functional areas such as analytical, microbiology testing, Environmental Monitoring, raw materials, stability, and sample management. This role will be responsible for documentation that is compliant with all applicable procedures, standards, and cGMP regulations.


Primary Responsibilities:


Serve as a project leader in the implementation and roll out of the Companys LIMS platform


Liaison with QA, QC, and IT to understand the user requirements and requests and communicate with developers to ensure proper development of the system


Describe workflow into software requirements, execute and review and 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 LIMS


Ensure LIMS system compliance 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 for each functional area


Author, revise, implement, and manage LIMS 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 QC LIMS related change controls, NC, CAPAs


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


Track and troubleshoot LIMS support program issues


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


Conduct risk assessments and champion continuous improvement


Other duties as assigned by management.


Knowledge, Skills & Abilities:


Knowledge of cGMP, ICH, pharmacopoeia, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.


Prefer experience with SampleManager or other LIMS systems.


Familiarity with routine analytical assays commonly performed on raw materials; knowledge of analytical methods such as Cell Based Assays, Flow Cytometry Assays, Microbiological assays, PCR is preferred


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.


Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment


Working knowledge of Deviations, Change Controls, and CAPAs


Strong written and verbal communication skills


Excellent interpersonal skills with experience dealing with all levels within the company


Willingness to collaborate internally and with clients while following regulations


Strong multi?tasking ability in conjunction with proven organizational and record keeping skills


Ability to organize assigned tasks in a fast-paced environment and monitor tasks / assignments that may impact timely completion with minimal supervision


Ability to effectively manage multiple tasks and activities simultaneously


Proficient computer skills in Microsoft Office Suite Word, Excel, PowerPoint, MS Project, MS Teams, Data Analysis Software, and other related applications


Competencies:


Effective communication skills in small and large group settings


Ability to lead complex topics in discussion and drive to resolutions


Ability to work independently and/or part of an internal team or clients with minimal supervision


Strong team player, able to meet deadlines and changing priorities


Strong Organizational and Time Management Skills


Understanding of cGMP regulations, preferably with Cell Therapy


Education & Professional Experience:


Bachelors degree in Life Sciences, Engineering or Computer Science


Minimum of 4 years of work experience with LIMS 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


Strong knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferred


Solid understanding of 21CFR part 11 and GAMP5


Basic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standards


Prior laboratory experience is a plus, but not required


**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


**\#TJP2022_SPEC**


**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** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you 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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-18 Expires: 2022-07-25

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Sr. LIMS Administrator

Kelly Services
Arcadia, CA 91007

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