Current jobs related to Auditor II Quality Assurance - Sydney, New South Wales - CTI Clinical Trial and Consulting Services
-
Auditor
1 day ago
Sydney, New South Wales, Australia Department of Agriculture, Fisheries & Forestry Full timeWhy YOU are important to us and what impact will you have on the Compliance & Enforcement Division and the departments' goal.Our division protects Australia's biosecurity and trade systems by putting effective regulations, policies, controls and actions into place. Working with internal and external stakeholders, we monitor potential and actual biosecurity...
-
Quality and Assurance Manager
1 week ago
Sydney, New South Wales, Australia Egis Group Full timeCompany Description FHE (Fulton Hogan Egis O&M Pty Ltd delivers outstanding Asset Management, Maintenance and Incident Response services within the Transport Infrastructure space within Australia. Established in 2015 and growing with rapid expansion, FHE now services six motorways and tunnels. The variety of our experiences on Australia's largest road...
-
AML Assurance Auditor
2 weeks ago
Sydney, New South Wales, Australia bet365 Full timeAt bet365, we're one of the world's leading online gambling companies, revolutionising the industry since 2000. Founded by Denise Coates CBE, we now employ over 9,000 people and serve over 100 million customers in 27 languages. Our focus on In-Play betting has solidified our market-leading position, offering an unmatched experience across 96 sports and...
-
AML Assurance Auditor
2 weeks ago
Sydney, New South Wales, Australia Bet365 Full timeCompany DescriptionAt bet365, we're one of the world's leading online gambling companies, revolutionising the industry since 2000. Founded by Denise Coates CBE, we now employ over 9,000 people and serve over 100 million customers in 27 languages. Our focus on In-Play betting has solidified our market-leading position, offering an unmatched experience across...
-
AML Assurance Auditor
2 weeks ago
Sydney, New South Wales, Australia bet365 Full timeCompany Description At bet365, we're one of the world's leading online gambling companies, revolutionising the industry since 2000. Founded by Denise Coates CBE, we now employ over 9,000 people and serve over 100 million customers in 27 languages. Our focus on In-Play betting has solidified our market-leading position, offering an unmatched experience across...
-
Field Quality Auditor
2 weeks ago
Sydney, New South Wales, Australia Service Stream Full timePrimary LocationSA - Regency ParkJob Description SummaryWe are seeking a Field Quality Auditor to lead compliance and excellence in our telecommunications projects.About the RoleWHY JOIN US? – We set the standardAt Service Stream, we take pride in delivering high-quality work on critical infrastructure projects, and our nbn Field Module agreement is no...
-
Quality and Assurance Manager
1 week ago
Sydney, New South Wales, Australia Egis Group Full timeCompany DescriptionFHE (Fulton Hogan Egis O&M Pty Ltd delivers outstanding Asset Management, Maintenance and Incident Response services within the Transport Infrastructure space within Australia. Established in 2015 and growing with rapid expansion, FHE now services six motorways and tunnels. The variety of our experiences on Australia's largest road...
-
Management Systems Auditor
3 days ago
Sydney, New South Wales, Australia Intertek Full timeJoin our TeamWe are looking for a Lead Auditorbased in Sydney, interested in being a part of SAI Global - Intertek.Our Management Systems Auditors, manage a portfolio of clients related to industry experience while conducting External Audits against internationally recognised standards in (but not limited to):ISO 9001:2015 - Management SystemsISO 14001:2015...
-
IT Auditor
2 weeks ago
Sydney, New South Wales, Australia Resmed Full timeThe Finance team's goal is to be a trusted and collaborative partner to all the businesses and functional teams that we work with, bringing business acumen, financial expertise and insights to aid decision-making and deliver value to our stakeholders. We strive to generate value through providing specialist advice and making recommendations to optimize...
-
Quality Assurance Manager
2 weeks ago
Sydney, New South Wales, Australia EDU Holdings Limited Full timeAbout EDUEDU is an ASX-listed provider of tertiary education, specialising in Health and Community Services. We foster meaningful careers through high-quality education across our campuses in Sydney, Melbourne, Brisbane and Adelaide:Australian Learning Group (ALG): VET provider for international students. Learn more about ALG.Ikon Institute of Australia...
Auditor II Quality Assurance
2 weeks ago
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit
What You'll Do
- Host Sponsor audits of CTI and assure that issues from Sponsor audits are promptly communicated to the appropriate team members, assist with the development of a corrective action plan and facilitate resolution of all audit findings
- Host Regulatory Authority inspections of CTI. Assist the organization in preparation for, coordination, hosting, conduct, documentation and follow-up of regulatory inspections
- Clearly communicate and report (verbally and in writing) audit outcomes and escalating significant compliance concerns to project teams, QA and CTI management and sponsor contacts appropriately
- Prepare training materials and conducting training related to relevant QA topics for CTI staff
- Report, manage and follow deviations, complaints, issues, non-conformances and their related CAPAs
- Prepare audit plans for audits and projects and programs, as needed
- Conduct Vendor Audits, Internal System Audits, Site Audits and Computerized Systems and Database Validation Audits. Identify and follow-up on any unresolved audit findings identified in a Quality Assurance Audit
- Conduct Sponsor-contracted audits, such as: Clinical Study Report Audits, Clinical Protocol Audits, Clinical Database Audits, Investigator Site Audits, etc. on an ad hoc or scheduled basis as determined by the Sponsor and CTI management
- Assist with creation, review, revision and management of SOPs
- Provide content and/or present quality related information at capabilities presentations
- Assist with completion of RFIs related to Quality Management Systems
- Assist in the review of Quality Assurance agreements related to projects or client master service agreements
- International region-specific functions
What You'll Bring
- 3-5 years of related experience or relevant pharmaceutical and/or CRO experience in Quality Assurance
- Bachelor's Degree or equivalent combination of education and experience
- Certification in auditing (RQAP, ASQ) or other quality related certification
- Comprehensive understanding of GxP Guidelines, namely ICH/GCP Guidelines and relevant country specific regulations
- Excellent verbal and written communication skills
- Proficient in MS Office Suite
- Computer literacy in MS Word, Excel and PowerPoint
- Excellent prioritization and organizational skills
- Excellent analytical skills
- Ability to work effectively and successfully in a team environment
- Ability to think critically and creatively
Why CTI?
- Advance Your Career - We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department.
- Join an Award-Winning and Valued Team - We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program.
- Make a Lasting Impact - We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an
email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ) or from our verified LinkedIn page.
Please Note
- We will never communicate with you via Microsoft Teams or text message
- We will never ask for your bank account information at any point during the recruitment process
