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Priya
SR QA Analyst
Contacto
Competencias
Demonstrated experience with GMP documentation review.
Demonstrated experience with Audit preparation.
Demonstrated experience with Process improvement.
Demonstrated experience with Project coordination.
Demonstrated experience with Documentation management.
Educación
Resumen
Professional profile
Experiencia
SR QA Analyst
Lead QA review and approval of GMP documentation, including SOPs, Batch Production Records, deviation reports, CAPAs, change controls, and Drug Substance/Product Reports, ensuring compliance with cGMP and FDA guidelines.. Support Manufacturing and other cross-functional departments, including QC, Validation, and Engineering, by providing daily QA oversight and operational guidance.. Represent QA during regulatory, client, and internal audits—prepare documentation, manage responses, and ensure audit readiness.. Mentor and train new QA staff and cross-functional partners on documentation practices, GMP compliance, and internal procedures.. Identify and drive process improvements to enhance efficiency, data integrity, and inspection readiness.. Assist QA management with workload delegation when requested.. Escalate and communicate quality or regulatory risks to senior leadership; support continuous improvement through issue reporting and collaboration.
QA Analyst III
Reviewed and approved technical GMP documentation and final product records with minimal supervision, supporting product disposition and client release.. Provide QA support during internal, external, and supplier audits, ensuring thorough documentation, effective communication, and timely execution of corrective actions.. Collaborated cross-functionally to maintain compliance and resolve quality issues; provided QA input during manufacturing investigations.. Authored and revised Quality System documents to improve consistency and regulatory alignment.. Delivered technical guidance and on-the-job training for QA analysts, strengthening team competency in cGMP and documentation standards.. Supported site readiness for regulatory and client inspections through proactive audit preparation and documentation reviews.
QA Analyst II
Performed comprehensive QA functions, including document review, deviation and CAPA management, and final batch record inspection.. Evaluated Drug Substance/Product Reports for accuracy, process consistency, and data integrity.. Provided Inspection support by verifying document authenticity and data integrity to assure the readiness of requested documents.. Proposed and implemented documentation control and compliance improvements within the site QMS.. Acted as QA liaison to internal teams and external partners, facilitating timely issue resolution.
QA Analyst I
Supported document review, CAPA tracking, and product disposition for assigned client accounts.. Assisted with policy updates, data reporting, and audit support to ensure regulatory compliance.. Act as the main QA liaison for an assigned client, overseeing quality readiness through product disposition; perform product inspections and detailed review of executed batch records to support compliant and timely product release.. Contributed to QA inspection readiness through meticulous documentation and record review.
Quality Assurance Associate/ Document Control Specialist I
Managed controlled document lifecycle, including routing, approval, issuance, and archival in compliance with cGMP and internal procedures.. Maintain accurate, compliant electronic and physical archives to support data integrity, traceability, and audit readiness.. Collaborated in leading the implementation of Master Control software, expediting electronic document approval, instantly updating SOP training material, and significantly reducing paper usage.. Authored departmental SOPs and trained new staff in document control processes.. Supported internal, client, and regulatory audits through documentation retrieval and backroom support.
Inventory Specialist
Managed store inventory control, compliance, and staff training; supported audits and daily operations leadership.. Supported daily store operations with strong customer focus—answered phones, assisted with product inquiries, handled complaints, and coordinated holds/returns.. Balanced multiple priorities in a high-traffic environment; recognized for reliability, teamwork, and maintaining a calm, courteous demeanor during peak hours.
Project Coordinator/Administrative Assistant
Coordinated departmental projects and community outreach initiatives, ensuring timely execution, regulatory compliance, and accurate documentation.. Managed grant and contract documentation to support successful funding proposals, maintained confidential client data in accordance with HIPAA, and collaborated with internal teams and local authorities to streamline communication and reporting.. Supported departmental leadership by preparing performance reports, tracking project milestones, and implementing organizational improvements to enhance overall efficiency and accountability.. Handled high-volume inbound/outbound calls on a multi-line system to coordinate appointments, confirm attendance, and conduct outreach.