Clinical Practices Auditor

Overview

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

Position:
Good Clinical Practices Auditor supporting the QA Compliance Team in Fort Worth, TX, Durham, NC, Johns Creek, GA, or Lake Forest, CA
.

• Planning, conducting, and handling GCP (remote or onsite) and/or other types of GXP audits under limited supervision.
• Supporting and contributing to 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, including technical mentorship, leadership, and training of audit-related activities; performing the auditor certification process and assessments for new auditors.
• Providing mentorship, review, and approval of associated deviations (NCI, and CAPAs).
• Leading and supporting the investigation of deviations and other quality issues detected from any source, and 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.

• Bachelor’s Degree or equivalent years of directly related experience (or high school +10 yrs; Associate +6 yrs; M.S. +0 yrs)
• The ability to fluently read, write, understand and communicate in English
• 2 years of relevant experience; worksite location: onsite
• Travel: 60% Intl/Dom.
• Relocation:
  No
• Sponsorship Assistance:
  No

• Knowledge of ISO 14155, ICH E6, Medical Device EU, FDA regulatory requirements, and Declaration of Helsinki
• Validated GCP audit track record
• Good analytical skills and judgment
• Advocate for outstanding quality and compliance standards – does not compromise on customer expectations and regulatory requirements

• Collaborate with teammates to share standard processes and findings as work evolves
• See your career like never before with focused growth and development opportunities
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career
• Alcon provides a robust benefits package including health, life, retirement, flexible time off and much more

Alcon Careers:
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Attention:
Current Alcon Employee/Contingent Worker. If you are currently an active employee/contingent worker at Alcon, please click the Internal Career site to apply.

Total Rewards:
Alcon’s Total Rewards programs are designed to align incentives with business goals, encourage the right values and behaviors, and deliver long-term value. Our rewards include compensation (fixed and variable) and a benefits program that supports life events, retirement, health and wellbeing, and family needs.

Pay Range: $75,000.00 - $

Pay Frequency:
Annual

Alcon is an Equal Opportunity Employer and participates in E-Verify. We are committed to a diverse environment and do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. If you need a reasonable accommodation for any part of the application process or to perform essential functions, please email .