Quality Analyst

Job Description: Pay Range: $24.69hr - $29.69hr Responsibilities: Process Know Your Customer applications to purchase SPRAVATO . (50%) Conduct routine data analysis for Suspicious Order Monitoring. (10%). Process day-to-day product quality complaint (PQC) in quality systems including evaluating PQC, assigning investigation, conducting investigation, writing investigation summary. Proactively manage PQCs workflow with stakeholders to ensure all investigations are completed in a timely manner. (10%). Process day-to-day quality events and change control records in TrackWise/COMET system (10%). Coordinate documents and procedures in true Vault system and any other document management system.(10%). Coordinate internal and/or supplier audits including setting up logistics / preparation for the audits, drafting audit plan, supporting audit execution, coordinating audit response and CAPA with stakeholders, creating and documenting audit records in TrackWise system. Ensure all audit commitments are delivered on time (10%). Required: BA/BS Technical / Life Science. Desirable: MA/MS/MBA Business / Technical /Life Science. Support Quality and Compliance Initiatives from Enterprise Quality and/or Global Business Quality. Essential Knowledge and Skills Knowledge: 5 years experience in the Pharmaceutical or related industry; Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP; Up-to-date knowledge of DEA regulations. Experience working in a quality organization. Skills: Highly experienced in TrackWise/COMET system, generating query and report, and data analysis with excel spreadsheet. Results-driven leader who commits to stretch goals and delivers results. Ability to build and nurture strong, positive relationships with business partners in IT, Manufacturing, Regulatory Affairs, Commercial and Quality functional groups. Demonstrated understanding of regulatory requirements that impact Market Quality specifically, and client's more broadly. Experience in dealing with regulatory inspections and inspectional. requirements Core Competencies: Credo Values. Innovation. Masters Complexity. Customer/ Marketplace Focus. Independent Partnering.

Created: 2025-09-22