Senior QA Specialist: Biopharma Validation & Batch Release

Scorpion Therapeutics; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Novo Nordisk in Clayton, NC seeks a Quality Assurance specialist overseeing production validation and batch release at our API manufacturing facility. You will ensure regulatory compliance and review batch documentation, deviations, change controls, and SOPs, while supporting validation projects and quality issue resolution.

Requirements include a Bachelor's in Life Sciences, Engineering, or related field, at least 5 years in pharmaceutical manufacturing, and strong knowledge of cGMP,

Qualifications

• Bachelor's in Life Sciences, Engineering, or related field.
• Minimum 5 years in pharmaceutical manufacturing.
• Strong knowledge of cGMP, validation, and quality management systems.
• Experience with batch review, deviations, and change controls.
• Excellent communication and computer skills.

Responsibilities

• Ensure regulatory compliance.
• Review and approve batch documentation, deviations, change controls, and SOPs.
• Support validation projects and quality issue resolution.
• Participate in root-cause analysis, process confirmations, and quality oversight.
• Act as an authorized person per Novo Nordisk Quality Manual.

Skills

cGMP knowledge

validation

quality management systems

batch review

deviations

change controls

communication skills

computer skills

Education

Bachelor's in Life Sciences, Engineering, or related field

Job description

Novo Nordisk in Clayton, NC seeks a Quality Assurance specialist overseeing production validation and batch release at our API manufacturing facility. You will ensure regulatory compliance and review batch documentation, deviations, change controls, and SOPs, while supporting validation projects and quality issue resolution.

Requirements include a Bachelor's in Life Sciences, Engineering, or related field, at least 5 years in pharmaceutical manufacturing, and strong knowledge of cGMP,