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Audit Coordinator

SQA Services is looking for a full-time Audit Coordinator to assist at a large medical device and pharmaceutical company in Pleasant Prairie, WI. SQA Associates in this role have at least 3 years of experience within the healthcare industry in a quality assurance administrative role. They will be highly knowledgeable in a variety of software applications and tools, including the MS Office Suite, traditional ERP systems and understanding of regulatory compliance requirements and environment. Each program coordinator will be trained to SQA's proprietary software, Step Q, prior to deployment.
Frequency: Full-time, 40 hours/wk
Duration: Temp-to-hire
Duties:
o Serve as on-site liaison between client and suppliers
o Conduct oral and written communication with internal customers, SQA Services auditors, and external suppliers for the purposes of audit preparation, audit agenda completion, audit scheduling, audit completion and CAPA follow-up completion and documentation.
o Client and/or SQA Services Auditor scheduling and coordination
o Works with all functional areas to ensure that Client's Supplier Quality Audits are in compliance with regulatory and internal requirement via collaborating with external suppliers, and partners with Client manufacturing sites, Global Supplier Auditing, procurement, R&D and program managers.
o Day-to-day Audit event and document management through SQA Services' proprietary software, StepQ. And Client Document Management system.
o Ancillary documentation obtained from the supplier such as copies of external certification, authorizations to manufacture, etc
o Approved status recommendation for each supplier
o Final audit reports, pre-audit checklist, audit agenda for each supplier approved by client
o Manage, review, and approve supplier audit responses/action plans (CAPA Plans) by obtaining and assessing the supplier's plan to correct audit observations.
o Monitor and report audit performance and supplier response metrics (audit completion timeliness, supplier audit CAPA Plan timeliness) to Management.
o Take appropriate proactive and reactive measures/actions with suppliers when supplier timeliness or actions are not meeting requirements.
o Escalate supplier timeliness or performance issues related to audit responses (CAPA Plans) to the Supplier Quality Group and management for resolution.

Requirements:
- 3+ years of experience in the healthcare industry in a Quality Assurance role
- Bachelor's degree or equivalent level of experience
- US Citizen or eligible to work in the US

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