Quality Assurance Specialist

Kriya Therapeutics•Durham, NC

51d•Onsite

About The Position

Kriya is a biopharmaceutical company focused on developing life-changing gene therapies for diseases with high unmet needs, particularly in metabolic disorders, neurology, and ophthalmology. The company utilizes a proprietary computational engine, in-house manufacturing, and an integrated design platform. Kriya has received recognition as Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” Forbes’ “America’s Best Startup Employers of 2024,” and BioSpace’s “2025 Best Places to Work.”

Requirements

Bachelor's degree in a scientific, engineering, or related discipline with 2+ years of cGMP Quality Assurance experience in biologics or pharmaceutical manufacturing, including direct experience with clinical labeling, batch record review, deviations, CAPAs, and change control.
Demonstrated experience authoring and reviewing SOPs and other controlled documents.
Strong attention to detail and ability to work cross-functionally with Manufacturing, Supply Chain, and Regulatory teams.
Ability to manage daily work activities of this role with minimal supervision.
An equivalent combination of education and experience will be considered.

Nice To Haves

Working knowledge of cGMP and applicable global regulatory requirements for clinical drug substance/drug product manufacturing and labeling is preferred.
Experience supporting site start-up activities, material onboarding, or risk assessments preferred.
Experience with electronic batch record (EBR) systems preferred.
Experience with quality oversite of Fill Finish operations and Visual Inspection reviews is preferred but not required.

Responsibilities

Provides timely Quality review and approval of clinical labels and executed clinical material labeling batch records.
Provides Quality input to Shiloh Glenn start-up projects, including the frozen Drug Substance/Drug Product project and Electronic Batch Record implementation.
Reviews and approves deviations, change controls, and CAPAs, ensuring investigations and corrective actions meet cGMP and Kriya quality standards.
Authors and approves SOPs and other controlled documents supporting clinical labeling and Shiloh Glenn Quality systems.
Participates in risk assessments and change control activities to support qualification of new materials during onboarding.
Provides on-the-floor Quality support for Manufacturing Operations, reviews executed batch records, and dispositions raw materials as Shiloh Glenn transitions to steady-state manufacturing (longer-term scope).