The Quality Assurance Specialist is a key support member of the Quality Department, responsible for helping ensure compliance with applicable regulatory, industry, and client requirements. The QA Specialist supports QA Management in maintaining adherence to ISO standards and the Quality Management System (QMS). This role collaborates with Operations and other departments to assist in the implementation and maintenance of systems that promote service quality, cost efficiency, customer satisfaction, and ongoing improvement of the Equipment Validation and Quality Management System. The QA Specialist provides support in auditing and monitoring processes related to internal storage, shipping and receiving, training, supplier qualification, new product introduction, change control, and corrective and preventive actions (CAPA) .Duties and Responsibilities:Supports the execution of validation and qualification activities in accordance with industry guidelines and customer requirements.Assists in maintaining validation documentation and records under supervision.Supports the review of validation, qualification, and verification documentation.Perform Quality review and verification on incoming and outgoing shipments and associated paperworkSupports the review and reconciliation of shipments as required.Review equipment logbooks, and documents.Assists in drafting Corrective and Preventive Actions (CAPAs) and participates in investigations as assigned.Assists in responding to customer feedback and in the investigation of complaints.Review and update standard operating procedures.Assists during on-site customer audits, supplier audits, and internal audits and supports Quality Assurance during audits by gathering documentation and assisting with audit-related tasks.Provides support to programs such as environmental monitoring, pest control, and equipment calibration/validation.Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any timeBasic knowledge of, and experience with, compliance to ISO, GDP, GDocP, cGMP, and/or CBER/CDER-regulated Quality Management SystemsSome experience assisting with validation activities and reviewing or interpreting validation dataFoundational understanding of basic statistical analysis methodsProficient in Microsoft Office programs (e.g., Word, Excel, Outlook, PowerPoint)Good written and verbal communication skillsAbility to prioritize tasks and manage workload under supervision to meet timelinesDemonstrates integrity and accountability in daily workAble to apply sound judgment and critical thinking to routine quality issuesProven ability to communicate with management and business leaders in a global operations settingUnderstanding USA/EU GDP processes standards2–5 years of experience working in a Quality related role in GxP facility