Quality Assurance Auditor

Company: Clario
Location: Medford
Posted on: November 16, 2021

Job Description:

OverviewClario. The Best of ERT & Bioclinica!--Are you an experienced Quality Assurance Auditor looking for an opportunity with a leading provider of endpoint technology solutions for clinical trials?----Clario is seeking an experienced Auditor to perform Quality Assurance audits and assessments of Clario's procedures and data to ensure compliance, and the quality of the services and systems developed and implemented by Clario.--Clario delivers the leading endpoint technology solutions for clinical trials. Through experience gained from over 19,000 clinical trials delivered in support of 870 regulatory approvals, Clario fuses scientific expertise and global scale into the broadest endpoint technology platform to enable pharmaceutical, biotech and medical device partners to transform lives. Through Trial Anywhere, Clario has mastered the ability to generate rich evidence across all trial models: decentralized, hybrid and site-based clinical trials. With 30 facilities in nine countries across North America, Europe and Asia Pacific, Clarios global team of science, technology and operational experts has been delivering the richest clinical evidence for nearly 50 years.----------------ResponsibilitiesAs a Quality Assurance Auditor with Clario you will:----

• Perform internal audits and gap analyses of Clarios operational and technical departments and processes to ensure compliance with Clario SOPs, Good Clinical Practices, and EN ISO 9001/ISO 13485 and applicable regulatory requirements. This includes all processes related to Clarios System Development Life Cycle.
• Perform audits of Clarios vendors to assess their Quality Management System, and their ability to meet Clario contractual agreements, Clario quality standards, and applicable regulations.
• Assist with the hosting and management of client audits. Analyze any observations identified and work with applicable departments to generate effective corrective and preventive action responses.
• Develop auditing plans and compile reports for assigned audits.
• Manage corrective action and preventive action responses received for internal and vendor audits, and responses defined for external audit observations. Conduct follow-up with the applicable departments to ensure timelines for corrective actions are met. --
• Perform tracking/trending analysis of audit findings.
• Perform quality reviews of key documents defined by Clarios System Development Life Cycle specifically related to Medical Device Development/Change Control; System Requirements; Testing/Validation Records; Installation Qualification; System Maintenance Records, and Migration Records
• Perform quality reviews to ensure the data and processes implemented by ERT are compliant with applicable regulations, guidelines, and internal procedures. This includes quality reviews of primary study documentation including raw data, reports, data listings, and FDA XML file deliverables as well as the establishment and training of ECG measurement criteria and alert ranges.
• Support Continuous Improvement program and conduct internal meetings to support management of issues.The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.QualificationsClario Quality Assurance Auditor Qualifications and Required Skills include:--
  • College (4-year) degree in Health/Life Sciences.
  • Minimum 2 years experience in a Quality Assurance capacity with a focus on GCPs and previous auditing experience.-- GMPs/experience with medical devices is a plus.
  • Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 and applicable regulatory authorities.
  • Excellent leadership, analytical, organizational and communication skills.
  • Detail oriented.
  • Ability to write concise and accurate audit reports.
  • Competent computer skills.
  • Ability and willingness to travel at least 10-15% of the time (international and domestic).What Clario Offers:--
    • Competitive Salary plus Annual bonus target
    • Excellent On-Boarding plan
    • Global Exchange ProgramExceptional Tuition Reimbursement program
    • Comprehensive Benefits PackageClario is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Join us!--#LI-LM1

Keywords: Clario, Medford , Quality Assurance Auditor, Accounting, Auditing , Medford, Massachusetts