- GE HealthCare (Boston, MA)
- …the quality management system (QMS) improvements. + Overall, the role of a GCP Quality Assurance Auditor is multifaceted, requiring strong attention to ... Description Summary** The Good Clinical Practice ( GCP ) Senior Quality Assurance (QA) Auditor is crucial in ensuring that clinical trials are conducted… more
- Philips (Orange, OH)
- …of the following (preferred): Successful completion of ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA), ... The Senior Good Clinical Practice ( GCP ) Auditor will play a critical...Studies and practices are compliant with Internal/External regulatory and quality standards. **Your role:** + Executing & leading Good… more
- AbbVie (North Chicago, IL)
- …to support the clinical trial conduct and their overall compliance with ICH GCP guidelines, applicable regulations, and the organization's Quality System. + ... Job Description Key Responsibilities + Responsible for ensuring high quality clinical trials are performed in compliance with worldwide...policies and procedures. + Plan, organize and lead multiple GCP vendor compliance audits on a global scale. +… more
- Caris Life Sciences (Phoenix, AZ)
- …such as MHLW Ord 169 (Japan) and MDSAP is a plus. + ASQ-CQA (American Society for Quality - Certified Quality Auditor ) or other auditor certification. + ... **Position Summary** + The Staff Quality System Auditor (Regulatory Compliance) is...13485, ISO 14971, FDA QSR (21 CFR Part 820), GCP regulations and 21 CFR Part 11. + Experience… 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) ... technology for communication and handling confidential information. **External-Facing Title:** Sr Auditor , Clinical Quality Assurance **Posting Country:** US -… 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...supporting non-clinical and clinical analysis in the GLP and GCP environment with Pharmacokineticists and Bioanalysts to ensure the… more
- PCI Pharma Services (Philadelphia, PA)
- …our global network to pioneer and shape the future of PCI. Job Title: Quality Auditor Department/Group: Quality Location: Philadelphia Reports to: Quality ... ensure within acceptable job parameters. Document audits using the Quality Auditor checklist listing the room, production...knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. Must be dependable in… more
- PCI Pharma Services (Philadelphia, PA)
- …and that hourly in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record review during batch processing ... within acceptable job parameters. + Document audits using the Quality Auditor checklist listing the room, production...knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures and rules. + May perform duties… 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
- AbbVie (North Chicago, IL)
- …for Quality (ASQ) Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA) Additional Information Applicable only to applicants applying to ... understanding of international GxP regulatory standards (eg GMP, GLP, GCP , GDP, GCLP, etc.), Quality Assurance /...(eg GMP, GLP, GCP , GDP, GCLP, etc.), Quality Assurance / Regulatory Affairs, Pharmaceutical / Device /… more
- PCI Pharma Services (Philadelphia, PA)
- …and that hourly in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record review during batch processing ... They are also responsible for leading and realizing continuous quality and process improvements on the production floor by...knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures and rules. + May perform duties… more
- Actalent (Edison, NJ)
- Actalent is hiring a GxP Auditor for a contract role. Preferred employees will possess prior Auditing experience (IS0 9001), and Vendor Audits. Description: Auditing ... * Independently leads the planning, conducting, and reporting of assigned GCP -GMP QA routine and non-routine GCP -GMP audits, including Clinical Investigator… 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...with NCTN clinical trial operations, data management, audit, and quality assurance is preferred. Education * Bachelor's degree from… more
- System One (Nashville, TN)
- …collect and analyze these + Preferred: Certified Clinical Research Professional, ASQ Certified Quality Auditor , ISO 9001 Certified Lead Auditor , or Certified ... by Corporate Quality , as appropriate, and the Quality Management Systems (QMS) processes to meet GCP... Quality Management Systems (QMS) processes to meet GCP and regulatory requirements in the conduct of clinical… more
- University of Pennsylvania (Philadelphia, PA)
- …actions and training related to research compliance, quality control and quality assurance. The monitor/ auditor will follow all DOCM policies and procedures ... of Operations, Compliance and Monitoring (DOCM) is seeking a clinical research monitor/ auditor to support our clinical research mission. The monitor/ auditor is… more
- Capital One (Mclean, VA)
- …function is a dedicated group of professionals focused on delivering top- quality assurance services to the organization's Audit Committee. Audit professionals are ... activities managing multiple priorities and tasks across the team to deliver quality results. -Coordinate with others and proactively take on additional work.… more
- PCI Pharma Services (Philadelphia, PA)
- …deliver a safe and quality product. This position will oversee both the Quality Auditor and Label Room teams. This is a supervisory position of approximately ... pioneer and shape the future of PCI. Job Title: Quality Operations Manager Department/Group: QC Inspection Location: Philadelphia Reports...Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. 13. Attendance to work is… more
- Boston University (Boston, MA)
- The Human Research Protection Program (HRPP) Human Research Quality Manager will perform quality assurance monitoring and auditing on human research studies ... at BMC and BU Medical Campus. The Human Research Quality Manager will evaluate and verify adherence to applicable...in positions such as IRB staff/analyst, study coordinator, or monitor/ auditor is needed. + Experience using REDCap preferred. +… more
- Capital One (Plano, TX)
- …function is a dedicated group of professionals focused on delivering top- quality assurance services to the organization's Audit Committee. Audit professionals are ... different perspectives into deliverables.** + **Manage timely and high quality delivery of multiple tasks, including audits, projects, special assignments,… more
- Capital One (Mclean, VA)
- …function is a dedicated group of professionals focused on delivering top- quality assurance services to the organization's Audit Committee. Audit professionals are ... multiple priorities and tasks across the team to deliver quality results.** + **Coordinate with others and proactively take...innovation, and technology will only make you a better auditor . This will require leveraging the power of data… more