Quality Assurance Area Specialist I – Durham

Novo Nordisk A/S; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Health insurance

401K match

Parental leave

Product access

Tuition assistance

Life Insurance

Disability insurance

Referral rewards

Paid holidays

Job summary

Novo Nordisk Durham site seeks a Quality Assurance Area Specialist I - SDF to ensure batch production records and QA processes meet regulations and SOPs, with accountability for QA approvals, deviations, and change requests.

You will perform self-audits, participate in investigations using LEAN tools, and support process confirmations on the shop floor, reporting to the QA manager and contributing to site quality improvements.

Qualifications

• Associate’s degree in life sciences or related field from an accredited college required.
• Bachelor’s degree preferred.
• Minimum of two years QA and/or quality related, or API experience required, preferably in the pharmaceutical industry.
• Quality Experience preferred.
• Basic computer skills in MS Office, MS Project, PowerPoint, etc. required

Responsibilities

• Ensure site compliance with Regulations, ISO standards, corporate & local SOPs
• Review & approve documentation for Quality approval – batch records and other documentation
• Support, review & approve investigations & root-cause analysis using LEAN tools and continuous improvement
• Participate in process confirmations & Go Look Sees
• Evaluate trend & report data for QMRs & APR reports
• Perform QA role to review and approve local production related Customer Complaint Investigations
• Participate in & support the audit management team as needed during internal, external audits and inspections
• Responsible for training of AP and FP members responsible for conducting investigations
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Skills

Quality Assurance

Self Audits

LEAN tools

Process improvement

Documentation review

Education

Associate’s degree in life sciences

Bachelor’s degree preferred

High School Diploma + 6 years QA exp

Tools

MS Office

MS Project

PowerPoint

Job description

Novo Nordisk Durham site seeks a Quality Assurance Area Specialist I - SDF to ensure batch production records and QA processes meet regulations and SOPs, with accountability for QA approvals, deviations, and change requests.

You will perform self-audits, participate in investigations using LEAN tools, and support process confirmations on the shop floor, reporting to the QA manager and contributing to site quality improvements.