QA Investigations Specialist (GMP & Lean)

BioSpace; Clayton (NC); On-site; USD 60,000 - 85,000; Full time

Job summary

Novo Nordisk's Clinical, Medical and Regulatory (CMR) team seeks a QA professional to timely review and close internal/customer complaints for US products packaged at IFP Clayton. You will collaborate across functions to investigate, test samples, and ensure corrective actions are implemented.

The role focuses on GMP compliance, root-cause analysis, and lean practices, requiring strong communication and problem-solving skills to support quality and patient safety.

Qualifications

• High School Diploma (GED) required.
• Bachelor’s degree in life sciences or related field preferred.
• Two years of QA and/or related experience in the pharmaceutical or medical device industry preferred.
• Demonstrated GMP knowledge and investigational/root cause analysis skills preferred.
• Knowledge of Novo Nordisk products and production processes preferred.
• Excellent written and verbal communication skills are preferred.

Responsibilities

• Review and approve complex cross-functional investigations related to Internal/Customer Complaints.
• Open packages and determine actions needed to complete investigations.
• Complete testing of samples to confirm complaints.
• Write Local Investigated Complaints and review product inspections for investigation planning.
• Ensure timely review and closure of Internal/Customer Complaints including CAPAs.
• Maintain customer complaint logs and coordinate with IFP, NNI and CCC.

Skills

Communication skills

Problem solving

LEAN

Education

Bachelor’s degree in life sciences or related field

High School Diploma (GED)

Tools

MS Office

MS Project

PowerPoint

LEAN tools

Job description

Novo Nordisk's Clinical, Medical and Regulatory (CMR) team seeks a QA professional to timely review and close internal/customer complaints for US products packaged at IFP Clayton. You will collaborate across functions to investigate, test samples, and ensure corrective actions are implemented.

The role focuses on GMP compliance, root-cause analysis, and lean practices, requiring strong communication and problem-solving skills to support quality and patient safety.