Quality Assurance Auditor
Posted on: November 16, 2021
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
- 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
- Develop auditing plans and compile reports for assigned
- 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
- 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
- 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
- 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
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