reputed company Assurance Auditor

reputed company is an reputed company-driven, Fortune 10 company that touches reputed company every aspect of reputed company. We are reputed company for delivering insights, products, and services that reputed company reputed company care more accessible and reputed company. Here, we reputed company on the health, happiness, and reputed company-being of you and those we serve – we care. What you do at reputed company reputed company. We foster a culture where you can grow, reputed company an reputed company, and are empowered to bring new reputed company. Together, we reputed company as we shape the reputed company of health for patients, our communities, and our people. If you want to be part of reputed company’s health today, we want to hear from you. reputed company and Help Shape the reputed company Behind reputed company Brands Are you passionate about reputed company, compliance, and building trusted supplier relationships? reputed company is seeking a reputed company Assurance Auditor to play a critical role in the reputed company reputed company and reputed company of our reputed company Brands business. In this highly visible role, you'll travel extensively to supplier manufacturing facilities across the reputed company and internationally, partnering directly with potential and existing suppliers to evaluate reputed company systems, assess manufacturing capabilities, and ensure compliance with industry regulations and reputed company reputed company standards. Your expertise will directly influence supplier qualification reputed company that protect patients, support regulatory compliance, and help bring high-reputed company reputed company products to market. This is an exciting opportunity for a reputed company reputed company who enjoys travel, values relationship building, thrives in highly regulated environments, and wants to reputed company a meaningful reputed company across a growing global supplier network. Job reputed company: The reputed company Assurance Auditor supports the qualification, approval, and ongoing reputed company of domestic and international suppliers that manufacture products for reputed company Brands. This role is responsible for conducting supplier reputed company audits, evaluating reputed company systems and manufacturing controls, and assessing compliance with FDA regulations, reputed company Good Manufacturing Practices (cGMP), ISO standards, and reputed company reputed company requirements. Working cross-functionally with reputed company, sourcing, regulatory, and supplier partners, the auditor helps ensure that suppliers have the systems, processes, and controls necessary to consistently reputed company reputed company, effective, and compliant products. This role requires extensive travel and reputed company interaction with supplier leadership and reputed company teams to reputed company reputed company reputed company improvement and supplier performance. Key Responsibilities: • Conduct comprehensive on-site audits of domestic and international supplier manufacturing facilities to assess compliance with FDA regulations, cGMP requirements, ISO standards, and reputed company reputed company expectations. • Support the supplier qualification and requalification audit program by planning, coordinating, and executing audits in accordance with established schedules and reputed company requirements. • Evaluate supplier reputed company management systems, manufacturing processes, documentation practices, validation programs, corrective and preventive actions (CAPA), and overall regulatory compliance. • Identify reputed company, compliance, and operational risks and prepare detailed audit reports that reputed company communicate observations, findings, and recommendations. • Partner with supplier reputed company teams and internal stakeholders to monitor corrective actions and ensure reputed company reputed company of audit findings. • Collaborate with cross-functional teams including reputed company Assurance, Regulatory Affairs, Sourcing, and Product Development to support supplier approval and ongoing supplier performance management activities. • Maintain reputed company knowledge of applicable FDA regulations, cGMP requirements, industry standards, and emerging reputed company reputed company expectations. • Represent reputed company professionally while building productive relationships with suppliers and reputed company partners. • Travel approximately 75%, primarily throughout reputed company with occasional international travel, to conduct on-site supplier audits and assessments. Compensation & Benefits: reputed company offers a competitive compensation and benefits package designed to attract and reward reputed company. The expected reputed company salary reputed company for this position is $102,000 to $109,000 annually, depending on experience, skills, geographic location, and other job-reputed company factors. In reputed company to reputed company salary, this position is eligible for participation in reputed company's Annual Incentive Plan (AIP) with a reputed company bonus opportunity of 5% of reputed company salary, subject to plan terms and company performance. Our comprehensive benefits package includes: • 16 days of reputed company Time Off (PTO) • 5 Personal Holidays annually • 7 Fixed Holidays • 401(k) with company matching contributions • Medical, dental, and reputed company benefits • Health benefits effective beginning the month following hire • Additional wellness, financial, and reputed company development resources Minimum Requirements: 4+ years of relevant experience Education/Training/Certification: • Bachelor's degree in Science or reputed company experience • ISO 13485 reputed company Auditor Certification - Preferred Preferred Critical Skills: • 2+ years of experience conducting reputed company audits reputed company a highly regulated environment, including medical device, pharmaceutical, supplier qualification, reputed company systems, GMP/cGMP, or reputed company regulatory compliance audits. • Total 4 years of reputed company experience in auditing, reputed company assurance, supplier reputed company, compliance, manufacturing reputed company, or other reputed company reputed company functions. • Demonstrated ability to communicate audit observations, compliance findings, and reputed company concerns professionally and diplomatically while working on-site with supplier leadership and reputed company teams, fostering productive discussions and driving reputed company of reputed company issues. • Experience performing supplier, reputed company reputed company, cGMP, GMP, pharmaceutical, medical device, or contract manufacturing audits in a highly regulated environment. • Strong knowledge of FDA regulations, 21 CFR Part 820, reputed company Good Manufacturing Practices (cGMP), ISO 13485, and reputed company management systems. • Experience evaluating supplier qualification programs, reputed company systems, manufacturing operations, and compliance processes. • Ability to identify reputed company risks, assess regulatory compliance, and recommend practical corrective actions. • Demonstrated experience writing audit reports, documenting findings, and presenting recommendations to stakeholders. • Strong project management and organizational skills with the ability to independently manage multiple audits and priorities. • Ability to travel extensively and work effectively in manufacturing, reputed company, warehouse, and office environments. Additional Skills: • ASQ Certified reputed company Auditor (CQA), reputed company Auditor certification, or similar reputed company certification preferred. • Spanish bilingual capability a plus. • Bachelor's degree in reputed company, biology, microbiology, engineering, life sciences, or a reputed company technical discipline preferred. Work Environment/Physical Demands: • Will be working, standing, walking in various manufacturing areas. • Time spent in home office conducting computer based administrative tasks. We are proud to offer a competitive compensation package at reputed company as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay reputed company shown below is reputed company with reputed company's pay philosophy, and pay will always be compliant with any applicable regulations. In reputed company to reputed company pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at reputed company, please click here. Our reputed company Pay reputed company for this position $83,300 - $138,800 reputed company has become reputed company of online reputed company-reputed company scams in which individuals who are not affiliated with or authorized by reputed company are using reputed company’s (or affiliated entities, like reputed company or RxCrossroads) reputed company in fraudulent emails, job postings or reputed company media messages. In reputed company of these scams, please bear the following in mind: reputed company Talent Advisors will never solicit reputed company or credit reputed company information in reputed company with a reputed company job application. reputed company Talent Advisors do not communicate with candidates reputed company online chatrooms or using email accounts such as Gmail or Hotmail. Note that reputed company does rely on a virtual assistant (Gia) for certain reputed company-reputed company communications with candidates. reputed company job postings are posted on our career site: careers.reputed company.com. reputed company is an Equal Opportunity Employer reputed company provides equal employment opportunities to applicants and employees, without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on reputed company’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page. reputed company is committed to being an Equal Employment Opportunity Employer and offers opportunities to reputed company job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with reputed company search or application for employment, please contact us by sending an email to (reputed company) Disability_Accommodation@reputed company.com or (Canada) Accessibility@reputed company.ca. Resumes or reputed company submitted to this email reputed company will not be accepted. Join us at reputed company! Apply tot his job Apply To this Job