Quality Auditor
2 months ago
Work Schedule Other Environmental Conditions Office Job Description Job Title: Quality Auditor As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Summary: The Quality Auditor will be responsible for assigned customer audits, regulatory inspections, and internal audits in accordance with established quality assurance processes, standards, federal and global regulatory guidelines and/or client contractual obligations. This position reports to the Quality Compliance Manager. Location: Cincinnati, OH - 2110 East Galbraith Road Quality Auditor Independently completes all aspects of regulatory inspections, customer audits, and internal audits, including, but not limited to, scheduling, documentation preparation, SME coordination, hosting, follow-up responses, and audit closure. Ensures on-time completion of audit activities with demonstrated interpersonal skills. Interprets FDA and international regulations, Standard Operating Procedures, and company policies for regulatory compliance. Maintain continuous education of current regulatory requirements. Partners with area leaders and subject matter experts for audit activities. Provides audit and inspection training as needed. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety Guidelines. Maintains the necessary compliance status required by company and facility standards. . Quality Compliance Responsible to initiate and maintain GMP questionnaires with vendors. Coordinate with quality, procurement, operations, and R&D globally to perform vendor audit activities. Quality Agreements: initiation, review and issuance for Commercial and Development Clients. Quality Agreements database periodic review to perform periodic reviews as identified. Knowledge, Skills, Abilities Clearly and accurately communicates in written and verbal form. Applies excellent problem-solving skills with a logical approach to resolutions. Strong decision-making skills. Ability to prioritize multiple ongoing activities, and to prioritize tasks. Outstanding attention to detail and organizational skills. Highly effective verbal and written communication skills at all levels. Excellent interpersonal skills to establish and maintain effective working relationships with employees and clients, including tact to handle critical matters. Ability to work in a fast-paced environment. Ability to maintain and manage high degree of confidentiality. Education: Bachelor of Science (B.Sc.) is preferred, or 4+ years of validated experience in GMP, GDP compliance and regulatory within the pharmaceutical industry. Experience: 3+ years in Pharmaceutical Industry preferably within the Quality Compliance, QA, Engineering, or Project Management. Extensive knowledge of GMPs, GDPs and Regulatory Affairs. Experience working with various clients is preferred Ability to work in a fast paced environment with changing priorities Our 4i Values: Integrity – Innovation – Intensity – Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Internal Auditor Sr.-SOX
4 weeks ago
Cincinnati, Ohio, United States Elevance Health Full timeInternal Auditor Sr. - SOX & SOC1 Location: Elevance Health supports a hybrid workplace model with pulse point sites used for collaboration, community, and connection. Proximity/within 50 miles to an Elevance Health major office (pulse point) is required. The Internal Auditor Sr.- SOX & SOC1 is responsible for responsible for conducting financial/operational...
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Internal Auditor II
2 weeks ago
Cincinnati, United States CECO Environmental Full timeJob DescriptionJob DescriptionPOSITION DESCRIPTIONPOSITION TITLE: Internal Auditor II DEPARTMENT: Finance and Accounting REPORTS TO: Senior Manager, Internal Auditor DATE CREATED: July 2024POSITION SUMMARYThe Internal Auditor II is responsible for performing internal audits, as part of the total internal audit plan. This responsibility includes performing...
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Overnight Night Auditor
3 weeks ago
Cincinnati, United States Renaissance Hotel - Cincinnati Full timeSupervise the night audit operations to ensure the maintenance of financial controls and compliance with hotel standards. Coordinate with other departments (i.e. security, housekeeping) to ensure quality service is provided to all guests.Responsibilities:Start the balancing, reconciliation, and closing of various daily accounts and prepare the daily...
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Internal Auditor Sr.-SOX
4 weeks ago
Cincinnati, United States Elevance Health Full timeInternal Auditor Sr. - SOX & SOC1 Location: Elevance Health supports a hybrid workplace model with pulse point sites used for collaboration, community, and connection. Proximity/within 50 miles to an Elevance Health major office (pulse point) is required. The Internal Auditor Sr.- SOX & SOC1 is responsible for responsible for conducting financial/operational...
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Cincinnati, United States Ensemble Health Partners Full timeThank you for considering a career at Ensemble Health Partners! Ensemble Health Partners is a leading provider of technology-enabled revenue cycle management solutions for health systems, including hospitals and affiliated physician groups. They offer end-to-end revenue cycle solutions as well as a comprehensive suite of point solutions to clients across...
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Director, Quality
2 months ago
Cincinnati, United States StandardAero Full timeBuild an Aviation Career You're Proud OfAt StandardAero, we use our ingenuity and know-how to find solutions for the simple to the most complex challenges in Aviation. Together, we get the job done and done well. Bring your mechanical aptitude, a strong work-ethic, and a hunger for learning - we'll teach you the rest.What's it like at...
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Director, Quality
4 weeks ago
Cincinnati, United States StandardAero Full timeBuild an Aviation Career You're Proud OfAt StandardAero, we use our ingenuity and know-how to find solutions for the simple to the most complex challenges in Aviation. Together, we get the job done and done well. Bring your mechanical aptitude, a strong work-ethic, and a hunger for learning - we'll teach you the rest.What's it like at...
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Senior Supplier Quality Specialist
2 weeks ago
Cincinnati, United States Germer International - Pharmaceutical Recruiting Full timeAre you looking to make the next move in your pharmaceutical career? Join our global pharmaceutical company, with approved products on the market, as the professional responsible for performing commercial Supplier Quality Management activities. This includes execution of pharmaceutical vendor audits, Quality agreements, lifecycle management, changes and...
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Senior Supplier Quality Specialist
1 week ago
Cincinnati, United States Germer International - Pharmaceutical Recruiting Full timeElevate your pharmaceutical career by joining a globally recognized company renowned for its innovative treatments and outstanding employee satisfaction. With a robust portfolio, our client is in great standing with the FDA and has received positive audits from international regulatory bodies.Our client is seeking a dedicated professional to manage...
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Laboratory Quality Assurance
2 weeks ago
Cincinnati, United States Medpace Full timeResponsibilities Manage Internal and External Laboratory related Audits according to current applicable Regulations; Coordinate, conduct and track company-wide Regulatory training and Quality Event Management; Management and oversight of departmental Standard Operating Procedures, forms and templates; Host Audits/Inspections by Sponsors and Regulatory...
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Quality Control Manager
7 days ago
Cincinnati, United States King City Gardens Full timeJob DescriptionJob DescriptionAs the Quality Manager, you will be responsible for overseeing and ensuring the quality of cannabis production processes. You will implement and manage quality control systems, procedures, and policies to ensure compliance with regulatory standards and maintain product integrity. Working closely with various departments, you...
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Director Quality Assurance and Regulatory Affairs
2 months ago
Cincinnati, United States Gateway Recruiting, INC. Full timeJob DescriptionJob DescriptionSUMMARY:The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Group Director of Quality Management and Regulatory Affairs.This role encompasses a...
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Cincinnati, United States Gateway Recruiting, INC. Full timeJob DescriptionJob DescriptionSUMMARY:The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Group Director of Quality Management and Regulatory Affairs.This role encompasses a...
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Director, Quality
2 months ago
Cincinnati, OH, United States StandardAero Full timeBuild an Aviation Career You're Proud OfAt StandardAero, we use our ingenuity and know-how to find solutions for the simple to the most complex challenges in Aviation. Together, we get the job done and done well. Bring your mechanical aptitude, a strong work-ethic, and a hunger for learning - we'll teach you the rest.What's it like at...
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Night Audit
2 weeks ago
Cincinnati, United States Laxmi Full timeJob DescriptionJob DescriptionSalary: The Night Auditor will responsible to conduct all nightly audit-related duties while providing guest service at the hotel's front desk. Audit responsibilities balancing duties, daily paperwork, and shift reports. While completing these duties, the Night Auditor will attend to guest needs such as guest...
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Night Audit
7 days ago
Cincinnati, United States Laxmi Full timeJob DescriptionJob DescriptionSalary: The Night Auditor will responsible to conduct all nightly audit-related duties while providing guest service at the hotel's front desk. Audit responsibilities balancing duties, daily paperwork, and shift reports. While completing these duties, the Night Auditor will attend to guest needs such as guest...
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Night Auditor
1 week ago
Cincinnati, United States The Westin Cincinnati Full timeAbout Us Join Our Vibrant Team at The Westin Cincinnati! Dive into a workplace that cherishes your contributions and fuels your growth! At The Westin Cincinnati, we're not just a team; we're a legacy. With each of our associates boasting an impressive tenure, we stand proud as a pinnacle of hospitality in the HEI Hotels & Resorts family. Our associates rave...
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Night Auditor
7 days ago
Cincinnati, United States The Westin Cincinnati Full timeAbout Us: Join Our Vibrant Team at The Westin Cincinnati! Dive into a workplace that cherishes your contributions and fuels your growth! At The Westin Cincinnati, we're not just a team; we're a legacy. With each of our associates boasting an impressive tenure, we stand proud as a pinnacle of hospitality in the HEI Hotels & Resorts family. Our associates...
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Audit Project Manager
4 weeks ago
Cincinnati, United States Fifth Third Bank Full timeMake banking a Fifth Third betterWe connect great people to great opportunities. Are you ready to take the next step? Discover a career in banking at Fifth Third Bank. GENERAL FUNCTION: Fifth Third Bank's Audit Division is responsible for performing independent, objective assurance activities for the Bank's key business processes, products, services, and...
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Audit Project Manager
1 month ago
Cincinnati, Ohio, United States Fifth Third Bank Full timeMake banking a Fifth Third betterWe connect great people to great opportunities. Are you ready to take the next step? Discover a career in banking at Fifth Third Bank.GENERAL FUNCTION:Fifth Third Bank's Audit Division is responsible for performing independent, objective assurance activities for the Bank's key business processes, products, services, and...
