Quality Assurance Specialist

Quality Assurance Specialist

Department: Quality Assurance

Employment Type: Full Time

Location: Research Triangle Park, NC

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.

We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of Bio Space’s “2025 Best Places to Work.”

This role provides support to Manufacturing, Supply Chain, and Clinical operations by providing reviews of batch production records and documents, raw material and consumable inspection and release, as well as review and approval for clinical labels and clinical material labeling batch records, ensuring labeling operations meet cGMP and applicable regulatory requirements prior to release. The role also provides Quality input to Shiloh Glenn site start-up activities, including risk assessments, the frozen Drug Substance/Drug Product project, new material onboarding, and Electronic Batch Record implementation, helping establish a compliant quality infrastructure as the site comes online.

As Shiloh Glenn transitions to steady-state operations, this role expands to include on-the-floor Quality support for Manufacturing Operations.

Key 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).

Experience & Skills

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

Work Environment

• Primarily desk-based, generally in an office or home office setting.
• May involve extended periods of sitting and computer use.
• Some lifting of equipment or materials may be required.
• Work may involve exposure to chemicals or biological materials; proper handling and disposal procedures must be followed.
• Must be able to don grade C and D level cleanroom gowning and work in a cleanroom environment.
• Must be willing to…