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Alcon · 12 hours ago

Good Clinical Practices Auditor

Durham – Emperor Blvd

Full-time

Onsite

Entry, Mid Level

$75K/yr - $125K/yr

2+ years exp

Alcon is a global leader in eye care, dedicated to helping people see brilliantly. The Good Clinical Practices Auditor will support the QA Compliance Team by planning and conducting GCP audits, ensuring compliance, and providing mentorship to clinical teams.

Health CareManufacturingMedical Device

No H1B

Responsibilities

Planning, conducting, and handling GCP (remote or onsite) and or other types of GXP audits under limited supervision

Supporting and chipping into the overall audit planning and scheduling process

Ensuring assigned audits are supervised appropriately and submitting audit plan change control documentation as needed

Ensuring audit observations are communicated appropriately to the Auditee and Senior Management

Ensuring the escalation process of critical observations is followed

Preparing and distributing audit reports according to Alcon’s requirements and timelines

Reviewing, evaluating, and approving proposed corrective and preventative action plans (CAPA) in collaboration with the responsible business partner

Providing mentorship and advice to clinical teams on GCP-related questions

Tracking, trending, interpreting, and presenting GCP compliance data for management metric review meetings and for continuous improvement

Supporting and preparing teams for regulatory inspections and/or corporate audits as advised

Entering and supervising Health Authority inspection information and reports in the database

Mentoring and training junior auditors, such as providing technical mentorship, leadership, training of audit-related activities, and performing the auditor certification process and assessments for new auditors

Providing mentorship, review, and approval of associated deviations (NCI, & CAPAs)

Leading and supporting the investigation of deviations and other quality issues detected from any source, being accountable for CAPA follow-up and verification activity jointly with Clinical Development

Providing QA support to Supplier Evaluation Teams as needed and conducting GXP audits as assigned

Staying current on activities in Clinical by reviewing the list of ongoing studies and attending Study Review and Project Kick-Off Meetings

Supporting additional CQA initiatives and other cross-functional duties as assigned

Qualification

GCP auditingISO 14155 knowledgeICH E6 knowledgeFDA regulatory knowledgeMedical Device EU knowledgeAnalytical skillsCommunication skillsMentorshipCollaboration