Overview
Quality Assurance Specialist Jobs in Durham, NC at i-Pharm GxP
Title: Quality Assurance Specialist
Company: i-Pharm GxP
Location: Durham, NC
QA Specialist – 6-Month Contract – RTP, North Carolina
I am supporting a confidential search for a QA Specialist to join a leading pharmaceutical client on an initial 6-month contract, based in Research Triangle Park (RTP), North Carolina. This role offers the opportunity to contribute to high-impact quality operations within a globally recognised organisation.
Overview of the Role
The QA Specialist will support key quality assurance activities for GMP manufacturing operations. This includes oversight of batch record review, deviation and CAPA management, and ensuring compliance with internal procedures and regulatory expectations. The role will collaborate with cross-functional teams including Manufacturing, Quality Control, and Regulatory Affairs.
Key Responsibilities:
• Review and approve manufacturing documentation including batch records, protocols, and reports.
• Support deviation investigations and CAPA implementation.
• Assist in maintaining inspection readiness and supporting internal and external audits.
• Ensure alignment with corporate quality policies and cGMP standards.
• Provide QA input during daily operations and project-based activities.
• Support continuous improvement initiatives within the QA function.
Experience and Requirements:
• Strong QA background within the pharmaceutical or biotech industry.
• Experience working in GMP-regulated environments.
• Demonstrated knowledge of deviation investigations, CAPA systems, and batch documentation review.
• Ability to work independently while engaging effectively with cross-functional teams.
• Previous experience with sterile or biologics manufacturing is a plus.
This is a confidential opening with a well-established and respected global client. If you are interested in learning more or would like to discuss the opportunity further, please get in touch directly.
