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Quality Compliance Auditor

3 months ago

Indianapolis, United States Randstad Full time

Our client is looking to hire a regulatory Quality Compliance Auditor to support the company's global quality assurance policies and compliance. This is a primarily remote position, but you MUST be able to come into the Indianapolis office when audits are being run, so MUST live a commutable distance from the office. This is a Temp To Hire opportunity. Qualifications: 6 years in regulatory environment (experience in GXP roles) Experience of industry quality systems/standards Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable Experience may be substituted for education. Responsibilities: Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample) Contributes to global QA policies on interpretation/application of regulations Provide subject matter expertise to projects. Support team in CAPA plan creation Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses Supports the QA–to-QA relationship with key client(s) Delivery of training in performance of audits (basic, intermediate, complex) Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization Supports the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings) Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed Other duties as assigned by management. Skills: Compliance Quality Assurance Regulatory Compliance - Other Good Manufacturing Practice Experience: Years of experience: 6 years Experience level: Experienced Education: Bachelors (required) Salary: $30 - $33.65 per hour Shift: First Work hours: 8 AM - 5 PM #J-18808-Ljbffr