System Administrator, Global LIMS

Orca Bio • Sacramento, CA

93d • $95,000 - $115,000

About The Position

Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies aimed at providing significantly better survival rates with dramatically fewer risks. The System Administrator, Global LIMS is pivotal in the implementation, administration, and ongoing management of the Laboratory Information Management System (LIMS) and supporting other enterprise systems. This role is critical in ensuring system reliability, data integrity, and compliance with regulatory requirements. The ideal candidate will have hands-on experience with enterprise-level system administration in a GMP regulated environment, strong problem-solving skills, and the ability to collaborate with cross-functional teams including IT, Quality, and Laboratory Operations.

Requirements

• 5+ years of experience with a Quality Control background in a regulated industry, such as antibodies, proteins, and reagent testing or pharmaceutical manufacturing.
• 3+ years of experience administering a LIMS system in a regulated (biotech, pharma, medical device) environment.
• Hands-on experience with electronic quality management systems (e.g. MasterControl, Veeva, TrackWise, etc.).
• Experience in FDA requirements for 21 CFR Part 11 (data integrity, audit trail review, and all other applicable compliance requirements).
• Excellent communication and collaboration skills, with the ability to work closely with cross-functional teams including IT and lab personnel.

Responsibilities

• Support the implementation and validation of a new LIMS system including requirements gathering, configuration and testing.
• Assist with configuration and administration of enterprise systems.
• Perform day-to-day administration for enterprise systems including user account provisioning, role/permission management and system configuration changes.
• Conduct periodic system and audit trail reviews to ensure compliance with 21 CFR Part 11, GxP regulations, and internal policies.
• Monitor system performance and troubleshoot issues.
• Support internal and external audits as needed for enterprise systems.
• Provide frontline support and assistance to LIMS end users to ensure end users can perform their day-to-day duties.
• Implement new modules for various enterprise systems to help shape the design, configurations, and workflows for future states.
• Support testing for enterprise systems including preparing test plans, evaluating test results for application implementations, modifications or upgrades.

Benefits

• $95,000 - $115,000 a year
• Pre-IPO equity
• Competitive medical, dental, and vision benefits
• Flexible PTO
• 401(k) plan
• Life and accidental death and disability coverage
• Parental leave benefits
• Free daily lunches and snacks at on-site locations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees