Specialist, Quality Control Lab

Denali Therapeutics•Salt Lake City, UT

26d

About The Position

This position supports and improves Quality Control laboratory operations across microbiology and chemistry departments. The role manages laboratory supplies and records, coordinates routine and stability testing, supports laboratory systems and equipment, and helps maintain organization, quality processes, and inspection readiness. It also provides administrative meeting support and may require on-call assistance outside normal business hours.

Requirements

Typically requires a BBS in Chemistry or equivalent science experience.
Ability to work independently and build productive relationships with internal teams and external sources.
Well-developed verbal and written communication skills.
Accuracy, right-first-time execution, and a proactive nature.
Strong collaboration and project management skills.
Ability to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, and stand for multiple hours at a time.

Nice To Haves

2+ years of experience working in GMP-regulated analytical and chemistry laboratories.
Knowledge of current USP, Ph. Eur., FDA, ISO, and GMP standards and guidance, and familiarity with quality systems.

Responsibilities

Ensure laboratory supplies, consumables, reagents, and solutions are purchased and available for analysts executing test methods.
Record and maintain reagents, lots, and validation samples in Labware LIMS.
Work with the stability coordinator to schedule, manage, and report the status of routine and stability testing for drug substance and drug product in Microbiology and Analytical Departments.
Coordinate with the Systems and Equipment Administrator as needed to support QC laboratory system or equipment needs.
Oversee general organization of the QC laboratory and laboratory activities.
Help log tasks, assign owners, drive accountability after meetings, and take meeting notes.
Help prepare for audits and inspections, track assigned quality actions, and support adherence to SOPs.
Clean glassware for analysts.
Maintain the laboratories in an inspection-ready state.
Work accurately and urgently, with a continuous-improvement perspective.
Provide on-call support outside normal business hours if required.