What are the responsibilities and job description for the Quality Assurance Engineer position at Staftonic LLC?
Quality Assurance Engineer
Location: Holly Springs, North Carolina
Long Term Project
We are seeking a Quality Assurance Engineer with pharmaceutical/biotech GMP experience to support quality, validation, and compliance activities within a regulated manufacturing environment.
Key Responsibilities:
- Support GMP/GxP compliance and quality operations.
- Review validation protocols, reports, and IQ/OQ/PQ documentation.
- Support equipment, process, cleaning, and CSV validation activities.
- Manage/review deviations, CAPA, change controls, and investigations.
- Review SOPs, batch records, protocols, and technical documents.
- Support FDA audits, inspections, and inspection readiness.
- Collaborate with Engineering, Manufacturing, Validation, QC, and Regulatory teams.
Requirements:
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related field.
- 3–7 years of QA/Quality Engineering experience in pharmaceutical, biotech, or regulated manufacturing.
- Strong knowledge of GMP, GxP, FDA regulations, and quality systems.
- Hands-on validation/qualification experience, including IQ/OQ/PQ, process validation, equipment qualification, or CSV.
- Strong documentation, investigation, and problem-solving skills.