QC Systems & Equipment Administrator - LabWare/Empower Pro

Denali Therapeutics; Salt Lake City (UT); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

401k

Healthcare coverage

Employee stock purchase plan (ESPP)

Career development opportunities

Job summary

Denali Therapeutics is seeking a QC Systems and Equipment Administrator to own the lifecycle of QC instruments and validated laboratory software, ensuring compliance with GMP and data integrity. This role partners with Engineering, IT, QA, and Validation to keep systems inspection-ready and drive workflow improvements.

The ideal candidate has a Bachelor's in a scientific field with 7+ years in GMP labs, hands-on instrument qualification, and experience administering QC software like Empower and

Qualifications

• Experience qualifying analytical instruments (IQ/OQ/PQ) and documenting results.
• Familiarity with 21 CFR Part 11, data integrity, and GMP expectations.
• Experience owning change controls, deviations, and CAPAs in eQMS.
• Ability to meet lab safety and material handling requirements.

Responsibilities

• Own QC equipment lifecycle from procurement to decommissioning.
• Maintain calibration and preventive maintenance schedules and records.
• Write IQ/OQ/PQ protocols and assess equipment reliability.
• Administer Empower, LabWare, Compass, 32 Karat, ViPR, OpenLab, and SoftMax Pro.
• Manage user access, change controls, and CSV documentation.
• Support audits with GMP documentation and technical writing.

Skills

GMP lab operations

Instrument qualification planning

Regulatory documentation

Cross-functional collaboration

Education

Bachelor’s degree in chemistry/biochemistry/engineering

MS degree with 4 years GMP experience

Tools

Waters Empower CDS

LabWare LIMS

ProteinSimple Compass

OpenLab

32 Karat

ViPR

SoftMax Pro

Job description

Denali Therapeutics is seeking a QC Systems and Equipment Administrator to own the lifecycle of QC instruments and validated laboratory software, ensuring compliance with GMP and data integrity. This role partners with Engineering, IT, QA, and Validation to keep systems inspection-ready and drive workflow improvements.

The ideal candidate has a Bachelor's in a scientific field with 7+ years in GMP labs, hands-on instrument qualification, and experience administering QC software like Empower and