Quality Assurance Specialist - Clinical Labeling & Start-Up

Kriya Therapeutics, Inc.; Milwaukee (WI); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Time Off & Work-Life Balance

Health & Wellness

Equity & 401(k)

Job summary

Kriya Therapeutics, Inc. is seeking a Quality Assurance professional to support manufacturing, supply chain, and clinical operations. You will review batch records and label material documentation, ensuring cGMP compliance and regulatory alignment.

The role includes QA input for site start-up activities, risk assessments, and electronic batch record implementation, expanding to on-the-floor support as operations scale.

Qualifications

• Bachelor's degree in a scientific, engineering, or related discipline with 2+ years of cGMP QA experience in biologics or pharmaceutical manufacturing.
• Familiarity with clinical labeling, batch record review, deviations, CAPAs, and change control.
• Experience with regulatory requirements for drug substance/drug product labeling.

Responsibilities

• Provides timely Quality review and approval of clinical labels and batch records.
• Contributes to Shiloh Glenn start-up projects and Electronic Batch Record implementation.
• Reviews deviations, change controls, and CAPAs to ensure cGMP compliance.
• Authors and approves SOPs and controlled documents for clinical labeling and QA systems.
• Supports risk assessments and qualification of new materials during onboarding.
• Provides on-the-floor QA support for manufacturing operations during steady-state transitions.

Skills

cGMP QA experience

Regulatory knowledge

Documentation

Cross-functional

Education

Bachelor's degree in science/engineering

Tools

Electronic Batch Record (EBR) systems

Job description

Kriya Therapeutics, Inc. is seeking a Quality Assurance professional to support manufacturing, supply chain, and clinical operations. You will review batch records and label material documentation, ensuring cGMP compliance and regulatory alignment.

The role includes QA input for site start-up activities, risk assessments, and electronic batch record implementation, expanding to on-the-floor support as operations scale.