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LIMS QC Admin & Analyst

San Marino, CA 91006

Posted: 01/26/2023 Employment Type: Direct Hire/Perm Job Category: LIMS Job Number: 485872 Is job remote?: No Country: United States

Job Description


LIMS Admin & Analyst – (Full-time) – Hybrid – CA

California Biotechnology Research Organization focused on providing personalized immunotherapies seeks a LIMS Quality Control Administrator for a partial onsite role. Ideal candidate will have LIMS prior Quality Control expertise with the ability serve as Administrator and Analyst. This individual will provide QC LIMS administration including implementation, development, configuration, validation, and maintenance for QC LIMS and other systems. Ideal candidate will lead and manage all QC LIMS functional needs to include environmental monitoring, raw materials, stability, and sample management. Opportunity offers strong benefits and compensation within a growing organization.

Responsibilities:
  • Collaborate with stakeholders in the creation of database requirements and system infrastructure
  • Liaise with vendors and IT regarding change controls, system assessments and improvements, implementations, and incident investigation
  • Provide end user training on system operations and day-to-day support.
  • Oversee user requirements gathering, design of specifications, configurations and collaborate with IT regarding correct development of lab systems used within GMP manufacturing.
  • Track and correct lab systems support issues and run risk assessments
  • Ensure compliance with all regulatory requirements and provide support for LIMS audits, in addition to implementing best practices on master data, LIMS development, configurations and reporting
  • Provide solutions and support to users as needed and implement and manage LIMS procedures for administrators and users
  • Serve as SME on master data set-up, the integration of equipment, validation requirements, and systems in relation to Manufacturing and QC
  • Lead the implementation of Sample Manager LIMS as applicable, and manage and develop related change controls such as CAPA’s
  • Support LIMS Sample Manager best practices to include QC LIMS change controls, development, master data, reporting and configurations, while tracking and resolving LIMS support program related issues.
  • Create and author SOPS and other LIMS requirements and workflows.
  • Receive and log  samples, perform data configurations for users, provide solutions for users based on individual needs and more.

Benefits:
  • Full-time hybrid opportunity with competitive base compensation commensurate with experience
  • Benefits to include Health, Dental, Vision and Life Insurance
  • 3% 401K match, plus additional 401K match opportunities
  • 2 weeks’ vacation; 2 floating holidays
  • 1-week sick leave plus additional leave available if needed

Requirements:
  • US Citizenship or Green Card Holder, with residency in the US
  • BS Degree in Engineering, or Computer\Life Sciences
  • 3+ years in biotech/pharma industries and extensive knowledge within regulated environments to include cGMP, ICH, and 21CFR part 11.
  • Expertise within LIMS and ideally Sample Manager LIMS (but not required)
  • Proficiency in Microsoft Office Suite

 
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