System Administrator, Global LIMS en Orcabiosystems

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 (e.g. MasterControl, electronic quality systems, etc.), as assigned by management. This person will play a critical role in ensuring system reliability, data integrity and compliance with regulatory requirements. The ideal candidate has hands-on experience with enterprise level system administration in a GMP regulated environment, with strong-problem solving skills and the ability collaborate with cross-functional teams including IT, Quality and Laboratory Operations.  

Physical Demands

Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.

Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

Work Conditions

Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.

Must be comfortable regularly participating in video-based meetings.

May be required to work scheduled overtime, weekends, or holidays based on business needs.

Essential Duties & Key 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 (including but not limited to GMP), 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. 

Minimum Experience, Education, Certifications, Licenses

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.

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