Good Clinical Practices Auditor

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. As a Good Clinical Practices Auditor supporting the QA Compliance Team in Fort Worth, TX, Durham, NC, Johns Creek, GA, or Lake Forest, CA, a typical day will include:

• 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.

WHAT YOU'LL BRING TO ALCON:

• Bachelor's Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+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

Preferred Experience:

• 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.

HOW YOU CAN THRIVE:

• 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.

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Alcon's Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcon's Corporate Social Responsibility including our Total Rewards, click here

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to 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. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.