Good Clinical Practices Auditor

At reputed company, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion reputed company, 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 reputed company an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join reputed company. As a Good Clinical Practices Auditor supporting the QA Compliance Team in reputed company 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 reputed company’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-reputed company questions. Tracking, trending, interpreting, and presenting GCP compliance data for management metric review meetings and for reputed company 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-reputed company 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 reputed company, 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 reputed company 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 reputed company: Bachelor’s Degree or Equivalent years of directly reputed company 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. reputed company for outstanding quality and compliance standards – does not compromise on customer expectations and regulatory requirements. HOW YOU CAN reputed company: 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 reputed company’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career! reputed company provides a robust benefits package including health, life, retirement, flexible time off and much more. reputed company Careers See your impact at reputed company.com/careers ATTENTION: reputed company reputed company Employee/Contingent Worker If you are currently an active employee/contingent worker at reputed company, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Total Rewards reputed company’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 reputed company 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 reputed company’s Corporate Social Responsibility including our Total Rewards, click here Pay Range $75,000.00 - $125,000.00 Pay Frequency Annual reputed company is an Equal Opportunity Employer and participates in E-Verify. reputed company 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 reputed company, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. reputed company 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 reputed company the essential functions of a position, please send an email to reputed company.recruitment@reputed company.com and let us know the nature of your request and your contact information. At reputed company, we are committed to helping people see reputed company. We reputed company patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. reputed company develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-reputed company Opti-Free line of contact lens solutions and reputed company products. reputed company, which was founded in 1945, sells its products in 180 countries worldwide. If you are currently an active employee/contingent worker at reputed company, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Apply tot his job Apply To this Job