Quality Assurance Area Specialist I (12-Hour Shift)

BioSpace; Durham (NC); Presencial; USD 70.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

Dental Insurance

Vision Insurance

8% 401K company match

Descripción de la vacante

Novo Nordisk is hiring for a Quality Assurance position in Durham, NC. The role ensures QA review and approval of change requests and batch records, with self-audits, line-of-business QA presence, and investigations using LEAN tools. Reports to the QA manager and works on 12-hour B shifts on site.

The role emphasizes regulatory compliance, ISO standards, and continuous improvement, with opportunities for training and career growth within Novo Nordisk’s QA organization.

Formación

• Associate degree in life sciences or related field required; Bachelor preferred.
• Minimum of two years QA and/or quality related experience; API experience preferred.
• At least six years of QA or related quality experience if HS diploma only.

Responsabilidades

• Ensure site compliance with regulations, ISO standards, and SOPs.
• Review and approve documentation for Quality approval, including batch records.
• Support investigations and root-cause analysis using LEAN tools.
• Participate in process confirmations and Go Look Sees.
• Analyze data for QMRs and APR reports; participate in audits.

Conocimientos

Excellent written and verbal comms

Educación

Associate’s degree in life sciences

Bachelor’s degree preferred

Herramientas

MS Office

MS Project

PowerPoint

Descripción del empleo

Novo Nordisk is hiring for a Quality Assurance position in Durham, NC. The role ensures QA review and approval of change requests and batch records, with self-audits, line-of-business QA presence, and investigations using LEAN tools. Reports to the QA manager and works on 12-hour B shifts on site.

The role emphasizes regulatory compliance, ISO standards, and continuous improvement, with opportunities for training and career growth within Novo Nordisk’s QA organization.