Quality Assurance Area Specialist I

Novo Nordisk • Clayton, NC

407d

About The Position

The Quality Assurance Area Specialist I at Novo Nordisk is responsible for ensuring compliance with regulations and standard operating procedures (SOPs) in the production of pharmaceutical products. This role involves reviewing and approving documentation, conducting self-audits, and supporting quality assurance processes on the shop floor. The specialist will work closely with the Senior Manager and participate in investigations, root-cause analysis, and audits to maintain high-quality standards in the manufacturing environment.

Requirements

• High School Diploma or equivalent (GED) required.
• Bachelor's degree in Life Sciences or a relevant field preferred.
• Minimum of two years of pharmaceutical or medical device experience required.
• Quality experience preferred.
• General knowledge of pharmaceutical regulations and quality systems preferred.
• Familiarity with local processes and quality systems preferred.
• Knowledge of Good Manufacturing Practices (GMPs) required.
• Excellent written and verbal communication skills required.
• Basic computer skills in MS Office, MS Project, PowerPoint, etc. required.

Nice To Haves

• Knowledge of Aseptic Production, Business Support, QC, Production Support, Warehousing/Transport, and/or Finished Production processes preferred.

Responsibilities

• Ensure Batch Production Records (BPRs) and relevant quality processes comply with regulations and SOPs.
• Accountable for Quality review and approval of Change Requests (CRs), Deviations, and other documentation.
• Perform self-audits in conjunction with line of business and provide QA presence on the shop floor.
• Review and approve documentation for Quality approval, including batch records.
• Support and review investigations and root-cause analysis using LEAN tools.
• Participate in process confirmations and Go Look Sees.
• Evaluate trends and report data for Quality Management Reviews (QMRs) and Annual Product Review (APR) reports.
• Review and approve local production-related Customer Complaint Investigations.
• Support the audit management team during internal and external audits and inspections.
• Train AP and FP members responsible for conducting investigations.

Benefits

• 401(k) with 8% match
• Paid holidays
• Disability insurance
• Health insurance
• Dental insurance
• Tuition reimbursement
• Paid time off
• Parental leave
• Vision insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: High school or GED