- Philips (Orange, OH)
- The Senior Good Clinical Practice ( GCP ) Auditor will play a critical role in ensuring Philips' Clinical Studies and practices are compliant with ... **Your role:** + Executing & leading Good Clinical Practice ( GCP ) audits in line with defined methodology. + Planning,...Successful completion of ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA),… more
- GE HealthCare (Boston, MA)
- **Job Description Summary** The Good Clinical Practice ( GCP ) Senior Quality Assurance (QA) Auditor is crucial in ensuring that clinical trials are conducted ... system (QMS) improvements. + Overall, the role of a GCP Quality Assurance Auditor is multifaceted, requiring strong attention to detail, analytical skills,… more
- AbbVie (North Chicago, IL)
- …support the clinical trial conduct and their overall compliance with ICH GCP guidelines, applicable regulations, and the organization's Quality System. + Appropriate ... current regulations, guidelines, policies and procedures. + Plan, organize and lead multiple GCP vendor compliance audits on a global scale. + Initiate, manage, and… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Research Auditor position is responsible for the development, coordination, and execution of program(s) involving the review of research ... with laws, regulations, International Council for Harmonization/Good Clinical Practice (ICH/ GCP ) and accreditation requirements, adherence to policy and procedures,… more
- Caris Life Sciences (Phoenix, AZ)
- **Position Summary** + The Staff Quality System Auditor (Regulatory Compliance) is responsible for conducting internal audits against the requirements of Caris ... 13485, ISO 14971, FDA QSR (21 CFR Part 820), GCP regulations and 21 CFR Part 11. + Experience...(eg BSI, TUV) audits. + Formal ISO 13485 lead auditor training or certification. + Conditions of Employment: Individuals… more
- Kelly Services (Spring House, PA)
- **Data Auditor (Quality Assurance)** Kelly Outsourcing & Consulting Group (Kelly OCG), a managed solution provider and business unit of Kelly Services, Inc., is ... currently seeking a Data Auditor ( Quality Assurance) for a long-term engagement at...supporting non-clinical and clinical analysis in the GLP and GCP environment with Pharmacokineticists and Bioanalysts to ensure the… more
- MicroVention, Inc. (Aliso Viejo, CA)
- **12071BR** **Title:** Sr Auditor , Clinical Quality Assurance **Job Description:** Provide support to all aspects of the Clinical Quality Assurance (CQA) function ... 2. Minimum of four (4) years of experience in clinical research and/or GCP related QA environment including auditing and/or external inspections (eg, BIMO). 3.… more
- IQVIA (Durham, NC)
- We are seeking a **Quality Assurance Auditor 2** to join Q2 Solutions, IQVIA's laboratory business in Durham, NC. We hire passionate innovators who drive healthcare ... as we transform and accelerate research and development. As a Quality Assurance Auditor 2, you will plan, conduct, and report assigned quality assurance audits,… more
- PCI Pharma Services (Philadelphia, PA)
- …to pioneer and shape the future of PCI. Job Title: Quality Auditor Department/Group: Quality Location: Philadelphia Reports to: Quality Operations Supervisor FLSA ... within acceptable job parameters. Document audits using the Quality Auditor checklist listing the room, production job description, and...knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. Must be dependable in… more
- PCI Pharma Services (Philadelphia, PA)
- …that hourly in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record review during batch processing in order ... acceptable job parameters. + Document audits using the Quality Auditor checklist listing the room, production job description, and...knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures and rules. + May perform duties… more
- System One (Philadelphia, PA)
- Job Title: Lead Auditor , Audit and Quality Control Type: Direct Hire/Permanent Schedule : Hybrid 2-3 days onsite in Philadelphia Experience * Must have experience in ... GCP auditing for clinical trials. * A minimum of...CTMB guidelines. * Review audit findings for compliance per GCP , OHRP, and FDA regulations. * Works with internal… more
- AbbVie (North Chicago, IL)
- …as: thorough understanding of international GxP regulatory standards (eg GMP, GLP, GCP , GDP, GCLP, etc.), Quality Assurance / Regulatory Affairs, Pharmaceutical / ... Society for Quality (ASQ) Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA) Additional Information Applicable only to applicants applying to a… more
- PCI Pharma Services (Philadelphia, PA)
- …that hourly in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record review during batch processing in order ... or weekend work + Must have knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures and rules. + May perform duties of a Quality Coordinator + May… more
- System One (Nashville, TN)
- …Quality, as appropriate, and the Quality Management Systems (QMS) processes to meet GCP and regulatory requirements in the conduct of clinical trials. You will also ... as necessary . Provide guidance to research operations on the interpretation of ICH- GCP , local and federal regulatory requirements as related to the conduct of… more
- University of Pennsylvania (Philadelphia, PA)
- …of Operations, Compliance and Monitoring (DOCM) is seeking a clinical research monitor/ auditor to support our clinical research mission. The monitor/ auditor is ... and training related to research compliance, quality control and quality assurance. The monitor/ auditor will follow all DOCM policies and procedures as well as have… more
- Capital One (Mclean, VA)
- …information, issues and audit progress to teammates, clients and auditor -in-charge. -Perform various aspects of engagement administration, including hours and ... innovation, and technology will only make you a better auditor . This will require leveraging the power of data...+ 1+ years experience in cloud computing (notably AWS, GCP , Azure) and controls, or 1+ years of conducting… more
- Capital One (Plano, TX)
- …understanding of data, innovation, and technology will only make you a better auditor . This will require leveraging the power of data analytics and furthering your ... pursuing certification related to Auditing, such as Certified Internal Auditor (CIA), or Certified Information Systems Auditor ...+ **4+ years experience in cloud computing (notably AWS, GCP , Azure) and controls, or 1+ years of conducting… more
- Capital One (Mclean, VA)
- …understanding of data, innovation, and technology will only make you a better auditor . This will require leveraging the power of data analytics and furthering your ... pursuing certification related to Auditing, such as Certified Internal Auditor (CIA), or Certified Information Systems Auditor ...+ **3+ years experience in cloud computing (notably AWS, GCP , Azure) and controls, or 1+ years of conducting… more
- Capital One (Mclean, VA)
- …understanding of data, innovation, and technology will only make you a better auditor . This will require leveraging the power of data analytics and furthering your ... pursuing certification related to Auditing, such as Certified Internal Auditor (CIA), or Certified Information Systems Auditor ...+ **3+ years experience in cloud computing (notably AWS, GCP , Azure) and controls, or 1+ years of conducting… more
- Weill Cornell Medical College (New York, NY)
- …+ Coordinate clinical trials in compliance with federal regulations, GCP guidelines, and internal policies. Ensures prioritization and execution of ... trials in conjunction with all pertinent staff, including: the monitor/ auditor , the regulatory office, investigational pharmacy, and investigators. + Maintains… more