Quality Assurance Specialist

Job Title: Quality Assurance Specialist – Sterile Manufacturing Location: FL (Onsite) Duration: 12 Months Overview The Quality Assurance Specialist will provide quality oversight for sterile manufacturing operations, with a primary focus on aseptic vial filling and fill-finish activities. This role ensures that manufacturing processes comply with cGMP requirements and internal quality systems while supporting inspection-ready operations. Responsibilities Provide QA oversight for aseptic vial filling, stoppering, and capping operations. Review and approve batch records associated with sterile manufacturing and fill-finish processes. Support and manage deviations, investigations, CAPA, and change controls related to fill-finish activities. Ensure compliance with cGMP, GDP, FDA regulations, and internal quality standards. Participate in and support internal and external audits, inspections, and quality risk assessments. Partner with Manufacturing and Validation teams to maintain inspection readiness and continuous compliance. Qualifications 5–8 years of Quality Assurance experience in sterile or injectable pharmaceutical manufacturing environments. Direct QA experience supporting aseptic vial filling and fill-finish operations. Strong working knowledge of cGMP and FDA regulations. Experience reviewing batch records and managing quality events related to sterile manufacturing. Strong documentation, communication, and problem-solving skills. #J-18808-Ljbffr