Supports the complaint handling process by ensuring complaints are received, documented, evaluated, and tracked in compliance with FDA and ISO regulations.
Responsibilities
Receive, acknowledge, and log feedback from all sources
Create complete and accurate complaint records
Perform initial triage to determine complaint definition and patient safety impact
Escalate reportable events to Complaint Manager and Regulatory Affairs
Follow up with complainants to obtain missing information
Requirements
Bachelor's degree in science, engineering, or related field
Nice to have: Regulated industry experience
Nice to have: Familiarity with EU MDR vigilance requirements
Responsible for investigating, documenting, and resolving manufacturing deviations in a sterile pharmaceutical environment.
Responsibilities
Author and support deviation investigations associated with sterile pharmaceutical manufacturing operations within Building 16
Develop clear, accurate, and comprehensive investigation reports that document the sequence of events, investigation findings, impact assessments, root cause analysis, corrective actions, and conclusions
Gather and evaluate information from manufacturing batch records, equipment logs, electronic systems, procedures, and other relevant documentation
Conduct interviews with manufacturing personnel and subject matter experts to establish factual event timelines and support investigation findings
Collaborate with cross-functional teams to identify potential contributing factors and determine appropriate investigation scope
Requirements
Associate's degree in a scientific, technical, engineering, or related discipline with 1 year relevant experience
Bachelor's degree in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or a related field preferred
Responsible for administering, maintaining, and continuously improving Apnimed's electronic Quality Management System (eQMS) and associated quality processes, ensuring inspection readiness and supporting regulatory compliance.
Compensation
The expected annual base salary range for this role is $170,000.00 to $190,000.00.
Responsibilities
Serve as subject matter expert and administrator for the electronic Quality Management System (eQMS), evaluating proposed system changes and coordinating testing, validation, and deployment activities.
Support the integration of new business processes, departments, and vendors into the Quality Management System, and oversee onboarding, knowledge transfer, and competency requirements for new eQMS administrators.
Maintain system documentation, including procedures, work instructions, validation documentation, and configuration records.
Administer the training program: confirm assignments and curricula reflect quality system responsibilities, manage role-based eQMS training and user support, and maintain a centralized library of user guidance, job aids, and FAQs.
Provide oversight and support for core quality processes, including document control, deviations, CAPAs, change controls, investigations, supplier quality records, and training management.
Requirements
Bachelor's degree or equivalent in a scientific, technical, engineering, quality, or related discipline.
Product Assurance Complaint AnalystHISTOSONICS INC · Plymouth, US