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 youll 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 Alcons 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 YOULL BRING TO ALCON:

• Bachelors 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 Alcons 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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Alcons 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 Alcons 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 and let us know the nature of your request and your contact information.