Quality Assurance Area Specialist I - SDF

Role: QA Specialist ensuring compliance of batch production records and quality processes in pharmaceutical manufacturing. Responsibilities: review and approve documentation, support investigations, conduct self-audits, participate in process confirmations, trend data analysis for QMRs and APRs, and support audit activities. Qualifications: Associate’s degree in life sciences or related field required; Bachelor’s preferred; minimum six years’ QA or related experience if holding a high school diploma/GED; at least two years of QA/industry experience, preferably in pharma. High-Value: pharmaceutical manufacturing, quality assurance, regulatory compliance, audits, investigations, experience with sterile/aseptic processes preferred. WorkSetup: onsite in Durham, NC, with physical requirements including lifting, standing, and working in noisy environments.