Quality Control (QC) Systems & Equipment Administrator

Denali Therapeutics•Salt Lake City, UT

15d

About The Position

The Quality Control (QC) Systems & Equipment Administrator owns the qualified state of Quality Control laboratory instruments and the validated state of QC computerized systems, including Waters Empower, LabWare LIMS, ProteinSimple Compass, SciEx 32 Karat, Revvity ViPER, Agilent OpenLab, Molecular Devices SoftMax Pro, and associated instrument software. The role is the single QC point of accountability for equipment lifecycle management, qualification, calibration and preventive-maintenance scheduling, return-to-service, application administration, and the quality-system records governing these activities. The incumbent works directly with Engineering, IT, Quality Assurance, Validation, Procurement, and external vendors to keep instruments in service and systems inspection-ready, while driving improvements to LabWare and Empower workflows. To preserve independence between system administration and record generation, this role does not generate or review GMP release or stability test records in the systems it administers.

Requirements

Typically requires a bachelor's degree in chemistry, biochemistry, engineering, or a related scientific or technical discipline and 7 or more years of experience in a GMP-regulated laboratory environment supporting analytical instruments and/or laboratory computerized systems; alternatively, a master's degree with 4 years of experience.
Hands-on experience qualifying analytical instruments such as HPLC/UPLC, icIEF/CE, spectrophotometers, balances, pH meters, and osmolality meters, and authoring IQ/OQ/PQ documentation.
Hands-on administration of at least one GMP laboratory computerized system, such as Waters Empower CDS, LabWare LIMS, or ProteinSimple Compass.
Working knowledge of 21 CFR Parts 11 and 211, FDA data integrity expectations, GAMP 5, and USP <1058>.
Experience owning change controls, deviations, and CAPAs in an electronic quality management system.
Ability to meet laboratory physical requirements, including specialized gowning, lifting and manipulating items greater than 25 lbs, climbing ladders, and standing for extended periods.
Technical writing to GMP documentation standards.
Structured troubleshooting and root-cause analysis.
Ability to prioritize across competing instrument and system demands.
Clear communication with analysts, QA, IT, Engineering, and vendors.

Nice To Haves

LabWare LIMS configuration and administration experience.
Empower administration experience, including projects, users, privileges, custom fields, and system policies.
Exposure to EU GMP Annex 11 and Annex 15.
Experience serving as an equipment or systems subject-matter expert during regulatory inspections.

Responsibilities

Manage the QC equipment lifecycle, including procurement, installation, qualification (IQ/OQ/PQ), routine use, relocation, and decommissioning.
Maintain calibration and preventive-maintenance schedules and records, and ensure compliance with applicable 21 CFR requirements; coordinate servicing, repairs, out-of-tolerance investigations, and return-to-service activities.
Author and execute equipment qualification and requalification protocols, assess equipment reliability, and recommend repair or replacement.
Administer QC computerized systems, including Empower, LabWare, Compass, 32 Karat, ViPR, OpenLab, and SoftMax Pro, in partnership with IT.
Manage user access, roles, privileges, periodic access reviews, system configurations, and master data under change control.
Oversee system backups, archives, recovery testing, audit trail reviews, periodic system reviews, and computerized system validation documentation.
Provide system support and training, and drive system enhancements, workflow automation, LIMS integration, and reporting improvements.
Own change controls, deviations, CAPAs, risk assessments, and effectiveness checks related to QC equipment and computerized systems.
Develop and maintain SOPs, work instructions, and forms; serve as a QC subject-matter expert during audits and regulatory inspections.
Monitor compliance metrics and partner with Engineering, Validation, and IT on equipment reliability, capital planning, vendor management, and continuous improvement.