Senior QA Specialist – Validation & Compliance

BioSpace; Clayton (NC); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Paid holidays

Parental leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk seeks a Site Clayton QA Finished Production representative to ensure batch release and quality oversight for validation activities. You will review complex CRs, DV/CA PA documentation, and provide coaching for audits while maintaining a validated state of equipment and processes.

The role requires strong GMP experience, regulatory knowledge, and ability to lead cross-functional investigations, with on-site Monday–Friday expectations in Clayton, NC.

Qualifications

• Minimum 7 years of QA experience in pharma/manufacturing settings.
• Experience with regulatory requirements (21 CFR Part 11, GAMP5, ISO).
• Expert in cGMP documentation and change control processes.
• Strong data integrity and statistical analysis knowledge.

Responsibilities

• Review and approve complex validation activities and related docs.
• Lead audits, inspections, and regulatory readiness on shop floor.
• Provide coaching on quality/compliance activities to site teams.
• Process improvement and CAPA/QMR/APR data review.
• Approve change controls, SOPs, and documentation updates.
• Support cross-functional investigations with root-cause analysis.

Skills

Quality Assurance

Regulatory Compliance

cGMP

Auditing

LEAN Six Sigma

Root Cause Analysis

Data Integrity

Validation

Problem Solving

Education

Bachelor’s degree in Life Sciences

High School Diploma or GED

Job description

Novo Nordisk seeks a Site Clayton QA Finished Production representative to ensure batch release and quality oversight for validation activities. You will review complex CRs, DV/CA PA documentation, and provide coaching for audits while maintaining a validated state of equipment and processes.

The role requires strong GMP experience, regulatory knowledge, and ability to lead cross-functional investigations, with on-site Monday–Friday expectations in Clayton, NC.