Clinical Labeling QA Specialist - Start-Up & Compliance

Kriya Therapeutics, Inc.; North Carolina; On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Health benefits

Paid time off

Job summary

Kriya Therapeutics, Inc. is seeking a Quality Assurance Specialist in RTP, NC to review clinical labeling and batch records, and support site start-up activities. The role ensures cGMP compliance and provides QA input to manufacturing and regulatory teams.

The candidate will review deviations, CAPAs, change controls, and SOPs, while supporting electronic batch records and on-floor quality during manufacturing transitions. A 2+ year QA background in biologics/pharma is needed.

Qualifications

• 2+ years of cGMP QA experience in biologics/pharma manufacturing.
• Experience with clinical labeling and batch records review.
• Experience with deviations, CAPAs, and change control and SOPs.

Responsibilities

• Provide timely Quality review and approval of clinical labels and labeling batch records.
• Provide QA input to site start-up projects (frozen Drug Substance/Drug Product, EBR implementation).
• Review deviations, change controls, and CAPAs to ensure investigations meet cGMP standards.
• Author and approve SOPs and controlled documents supporting clinical labeling and QA systems.
• Participate in risk assessments and onboarding material qualification.
• Provide on-the-floor QA support during manufacturing transitions.

Skills

cGMP QA experience

clinical labeling

batch record review

CAPA & change control

SOP authoring

cross-functional collaboration

attention to detail

Education

Bachelor's degree in science/engineering

Tools

EBR systems

Job description

Kriya Therapeutics, Inc. is seeking a Quality Assurance Specialist in RTP, NC to review clinical labeling and batch records, and support site start-up activities. The role ensures cGMP compliance and provides QA input to manufacturing and regulatory teams.

The candidate will review deviations, CAPAs, change controls, and SOPs, while supporting electronic batch records and on-floor quality during manufacturing transitions. A 2+ year QA background in biologics/pharma is needed.