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.
location: Arcadia, California
job type: Permanent
salary: $100,000 - 120,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
- Serve as a project leader in the implementation and roll out of the Company's 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.
qualifications:
- Bachelor's 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
skills: Biology, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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