Quality Assurance Specialist - Synerfac : Job Details

The purpose of the Quality Assurance Specialist is to perpetuate Enterprise-wide Quality and Regulatory compliance and continuous improvement through assisting with the implementation and maintenance of robust quality systems and processes and engaging with related projects.SYSTEM MANAGEMENT:1. Assist with the development and implementation of Quality Systems and processes, including the development and delivery of content, in accordance with Quality Objectives and in collaboration with team.2. Work collaboratively with internal customers including Corporate, to establish and achieve qualification objectives.3. Maintain applicable SOPs and processes.4. Participate in and provide necessary data/metrics required for Quality meetings5. Review batch records to determine compliance with all established and approved written procedures.6. Review, prepare, execute, approve, assist with, and maintain applicable Change Controls and Validation documentation for retrospective, concurrent, and prospective validation compliance specific to the Quality Management System.7. Assist with current and future processes and workflows in the QMS.Complaint/Nonconformance Investigations:1. Conduct investigation, documentation, and review and approval of non-conformances, CAPAs related to customer complaints.2. Effectively utilize product and quality knowledge to perform robust investigations leading to root cause, including review of retain product samples and associated production and batch record.Job RequirementsAUDITS, INSPECTIONS, AND COMMITMENTS:1. Participate in the organization and execution of audits and inspections, including personnel, requests, documentation, and process flow.2. Ensure accurate, thorough, and on-time completion of all Agency and Third-Party Commitments.3. Maintain documentation and records in accordance with regulations and internal policies.4. Compliance support may include, but is not limited to, the following:a. GMP and quality systems training,b. Internal and external audits,c. Preparation and support for partner audits,d. Gap assessments against SOPs, regulations, and industry standards.Bachelor of Science or Bachelor of Arts degree or equivalent. Relative work experience in a GMP environment may be considered in lieu of degree.At least 3 years in a Quality role in a GMP environment.Document Control System, CAPA/Complaint investigation working knowledge preferred.