More jobs:
Senior Quality Assurance Area Specialist ; QA or IT & Automation
Job in
Clayton, Johnston County, North Carolina, 27520, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Quality Engineering, Regulatory Compliance Specialist, Production QC/QA -
Pharmaceutical
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Quality Assurance specialist overseeing production validation and batch release at Novo Nordisk's API manufacturing facility.
Responsibilities- ensure compliance with regulatory standards
- review and approve batch documentation, deviations, change controls, and SOPs
- support validation projects and quality issue resolution
- participate in root-cause analysis, process confirmations, and quality oversight
- act as an authorized person per Novo Nordisk Quality Manual
- Bachelor's in Life Sciences, Engineering, or related field
- minimum 5 years in pharmaceutical manufacturing
- strong knowledge of cGMP, validation, and quality management systems
- experience with batch review, deviations, and change controls
- excellent communication and computer skills
- experience in biotech/pharma production environments
- process validation
- quality oversight
- expertise in cGMP manufacturing, validation processes, regulatory compliance, and batch review activities within a biopharma API context
reports to QA Manager, supports cross-functional teams on quality-related activities.
Work setupon-site at Clayton, NC, with physical demands including moving equipment, standing for long shifts, and working in noise-sensitive environments.
Position Requirements
10+ Years
work experience
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