QA Validation Specialist – Finished Production

Novo Nordisk A/S; Clayton (NC); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Paid time off including 14 paid holidays

Health Insurance, Dental Insurance, Vision Insurance

Tuition Assistance

401K contribution with company match

Job summary

Novo Nordisk A/S is seeking a QA Area Specialist III in Clayton, NC, focused on validation activities within Finished Production. This role involves quality oversight, decision-making on compliance issues, and ensuring adherence to regulations.

The ideal candidate will have significant experience in quality assurance, a strong understanding of pharmaceutical regulations, and the ability to lead improvement activities. Benefits include competitive pay, health insurance, and paid time off.

Qualifications

• 7+ years of QA and/or quality experience in pharmaceuticals.
• Experience with 21 CFR Part 11 and GAMP5.
• Auditing experience with certification preferred.

Responsibilities

• Ensure compliance with quality regulations and standards.
• Review and approve validation activities and documentation.
• Facilitate sharing of regulatory expectations.

Skills

Quality Risk Management

Regulatory compliance

LEAN and Six Sigma

Troubleshooting

Statistical methods

Education

High School Diploma or equivalent (GED)

Bachelor’s degree in Life Sciences

Tools

cGMP documentation practices

Root-cause analysis tools

Risk assessment

Job description

Novo Nordisk A/S is seeking a QA Area Specialist III in Clayton, NC, focused on validation activities within Finished Production. This role involves quality oversight, decision-making on compliance issues, and ensuring adherence to regulations.

The ideal candidate will have significant experience in quality assurance, a strong understanding of pharmaceutical regulations, and the ability to lead improvement activities. Benefits include competitive pay, health insurance, and paid time off.