Assist in the implementation, maintenance, and continuous improvement of the electronic Quality Management System (eQMS) to ensure compliance with FDA regulations.
Lead and coordinate Corrective and Preventive Action (CAPA) processes, including investigation, root cause analysis, implementation of corrective actions, and effectiveness checks.
Handle Customer Complaints and Out of Specification (OOS) investigations, ensuring timely resolution and documentation according to regulatory requirements.
Conduct thorough Internal Audits to assess compliance with established quality procedures, identify areas for improvement, and develop corrective actions as needed.
Collaborate with cross-functional teams to provide quality assurance guidance and support throughout all stages of operation.
Develop and maintain quality-related documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records, in accordance with FDA regulations.
Assist in the preparation and hosting of regulatory agency inspections and audits, as well as follow-up activities to address any findings or observations.
Stay abreast of regulatory requirements and industry best practices related to quality assurance and quality management systems, and proactively implement necessary changes to ensure compliance.

Bachelor's degree in a scientific or technical field, such as Chemistry, Biology, Engineering, or related discipline.
1-2 years of experience in a quality assurance role within an FDA regulated industry, preferably in pharmaceuticals, medical devices, or biotechnology.
Strong understanding of FDA regulations and guidelines, including cGMP, 21 CFR Part 11, and ICH guidelines.
Proven experience in managing electronic Quality Management Systems (eQMS), such as Qualtrax, Intact, or similar platforms.
Proficiency in conducting investigations, root cause analysis, and implementing corrective actions for CAPA, Customer Complaints, and OOS events.
Experience in conducting Internal Audits and familiarity with audit processes and methodologies.
Excellent communication skills, with the ability to effectively collaborate with cross-functional teams and communicate quality requirements to stakeholders at all levels of the organization.
Strong attention to detail and analytical skills, with the ability to analyze complex data sets and identify trends or areas for improvement.
Ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment.

Quality Assurance Coordinator

Key skills