QC Systems & Equipment Administrator (GMP/LIMS Expert)

Denali Therapeutics Inc; Salt Lake City (UT); On-site; USD 110,000 - 150,000; Full time

Job summary

Denali Therapeutics Inc in Salt Lake City seeks a QC Systems and Equipment Administrator to own the qualified state of QC laboratory instruments and validated QC computerized systems. You will manage instrument qualification, calibration, preventive maintenance, and change controls, partnering with IT, QA, Validation, and Engineering to keep systems inspection-ready.

The role requires a Bachelor's degree in chemistry/biochemistry/engineering or related field and 7+ years in a GMP-lab setting,

Qualifications

• Bachelor's degree in chemistry, biochemistry, engineering, or a related scientific/technical discipline.
• 7+ years of experience in a GMP-regulated laboratory environment supporting analytical instruments and/or laboratory computerized systems (or MS with 4 years).
• Hands-on experience qualifying analytical instruments (e.g., HPLC/UPLC, icIEF/CE, spectrophotometers, balances, pH and osmolality meters) and authoring IQ/OQ/PQ documentation.
• Hands-on administration of at least one GMP laboratory computerized system (e.g., Waters Empower CDS, LabWare LIMS, 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.

Responsibilities

• Manage the QC equipment lifecycle: procurement, installation, qualification, routine use, relocation, and decommissioning.
• Maintain calibration and preventive maintenance schedules, records, and compliance with 21 CFR requirements; coordinate servicing and return-to-service activities.
• Administer QC computerized systems (Empower, LabWare LIMS, Compass, 32 Karat, ViPR, OpenLab, SoftMax Pro) with IT; manage users and access reviews.
• Oversee backups, archives, audit trails, system validation documentation, and periodic system reviews.
• Develop SOPs, work instructions, and forms; act as QC SME during audits and regulatory inspections.
• Monitor compliance metrics and partner with Engineering, Validation, and IT on reliability and vendor management.

Skills

GMP knowledge

Technical writing

Cross-functional collaboration

Regulatory documentation

Education

Bachelor's degree in chemistry/biochemistry/engineering or related

Tools

LabWare LIMS

Waters Empower

ProteinSimple Compass

OpenLab

SoftMax Pro

32 Karat

Job description

Denali Therapeutics Inc in Salt Lake City seeks a QC Systems and Equipment Administrator to own the qualified state of QC laboratory instruments and validated QC computerized systems. You will manage instrument qualification, calibration, preventive maintenance, and change controls, partnering with IT, QA, Validation, and Engineering to keep systems inspection-ready.

The role requires a Bachelor's degree in chemistry/biochemistry/engineering or related field and 7+ years in a GMP-lab setting,