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Sr Quality Auditor, GCP

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

As a member of the quality team, the Sr Quality Auditor, GCP works collaboratively with groups throughout the organization to ensure compliance with regulatory requirements and to support a diverse array of projects and initiatives. This position contributes to QA activities across multiple quality system requirements, such as CLIA/CAP, GCP, ISO and FDA regulated environments.

Key Responsibilities

• Perform periodic audits of Good Clinical Practice activities which may include, but is not limited to, BioPharma and Clinical Operations procedures, processes, records, and reports.

• Prepare reports of audit and inspection observations.

• Discuss audit and inspection findings with management staff to develop appropriate corrective and preventive actions where appropriate.

• Assist with external audits performed by regulatory/inspection agencies or BioPharma/Clinical Operations Partners, as required.

• Assist with the compilation of audit findings for management purposes.

• Maintain current and accurate records of all relevant communications, audits, corrective action plans, and CAPA effectiveness monitoring, as required.

• Demonstrate strong proficiency in the application of the Corrective and Preventive Action (CAPA) system to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources.

• Maintain familiarity with BioPharma and Clinical Operations and relevant Laboratory operating and quality assurance/quality control procedures to effectively perform GCP quality assurance functions.

• Support, maintain and continually improve Quality System.

• Maintain availability to work outside of a regularly scheduled shift.

• Travel domestically up to 20% of the time.

• Support other duties, as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree or equivalent

• 4+ years of of clinical monitoring/Quality Assurance experience in the pharmaceutical, biotechnology, or diagnostic industries

Preferred Qualifications

• ASQ Quality Auditor certified

• Auditing Experience (Clinical Investigator Site / Vendor)

• Experience with Vendor Management

• Experience with managing GCP activities across multiple quality system requirements (e.g. operating under FDA, ISO, CLIA and CAP)

• Experience or familiarity with Companion Diagnostics or Clinical Lab operations

• Scientific background in molecular biology and/or NGS

• Understanding/working knowledge of ICH and GCP guidelines

• Ability to manage multiple projects and work independently

• Process-oriented, with the ability to demonstrate good judgment and decision-making

• Ability to identify quality issues and effectively interface with internal and external teams

• Strong attention to detail and the ability to manage multiple priorities with aggressive timelines

• Strong written and communication skills

• Ability to communicate clearly and concisely with all stakeholders

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

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