UTS - Temporary Quality Assurance Associate at UNC Chapel Hill

NC State University is hiring a Temporary Quality Assurance Associate for the UTS at UNC Chapel Hill. The role involves directing quality processes, managing document control, reviewing batch records, investigating deviations, supporting validation tasks, tracking QA metrics, inspecting materials, technical writing, and training QA/QC team members.

• Provide guidance on quality systems and processes to ACT facility employees.
• Manage document control ensuring proper revision, effectiveness, and archiving of facility documents.
• Assist with batch record creation, review executed records, and collaborate on corrections.
• Initiate and investigate deviations and implement Corrective and Preventive Actions (CAPA).
• Oversee and review validation work for compliance with established plans.
• Track QA system progress using internal auditing and error trending for KPIs.
• Inspect incoming materials for manufacturing specifications compliance.
• Write and update policies, SOPs, forms, and job aids.
• Train and collaborate with QA/QC team members and support manufacturing projects.
• Required skills include experience with Quality Assurance/Control in regulated manufacturing, proficiency with electronic Quality Management Systems (preferably Master Control), technical writing, deviation investigations, and maintaining EHS compliance.
• Minimum qualifications include a Bachelor's degree in Biology, Chemistry, Bioengineering, or related fields, or equivalent industry experience with 2-3 years in QA/QC roles.
• Compensation offered is $33.65 hourly.
• Preferred experience includes cellular therapy, biologics, blood banking, validation protocol oversight, CAPA authorship, and KPI tracking.