Jobs at Afton Scientific, LLC

Leads pharmaceutical production operations, supervises production leadership, coordinates manufacturing schedules, and ensures safe, efficient, compliant sterile manufacturing. Oversees training, employee development, quality documentation, deviations, change controls, audits, equipment maintenance, validation, and inspection readiness. The role requires hands-on support with aseptic processing, equipment setup, facility cleaning, and cleanroom operations while collaborating across Quality, Engineering, Facilities, Sales, and Operations.

Leads quality assurance oversight for sterile and non-sterile pharmaceutical manufacturing. Responsibilities include batch record review and lot release, deviation investigations, CAPA management, SOP and validation document approval, aseptic personnel qualification, audit and inspection readiness, quality metrics monitoring, regulatory compliance, and training QA and cross-functional personnel.

Operates and maintains isolator systems for aseptic filling of sterile injectable products. Performs cleaning, decontamination, setup, component handling, batch documentation, environmental monitoring, and equipment performance checks under GMP standards. Collaborates with Quality Assurance and Engineering to resolve issues, maintain compliance, complete training, and support continuous improvement in a controlled pharmaceutical manufacturing environment.

Administers and controls pharmaceutical documentation systems, including master documents, SOPs, batch records, protocols, specifications, change controls, and investigation records. Issues lot numbers and batch records, supports validation activities, reviews deviations, facilitates audits, and provides inspection support. The role requires strong cGMP knowledge, document management system experience, meticulous recordkeeping, and collaboration across Quality Assurance, Quality Control, Operations, clients, and vendors.