Agenus

GCP QA Auditor

US-MA-Lexington
Job ID
2017-1278
Category
Quality

Overview

The GCP QA Auditor will follow and oversee GCP audit programs.  This candidate will be responsible in assisting defining the GCPaudit schedule to ensure external and internal entities (including GcLP laboratories) and contract organizations meet all defined regulatory requirements. 

Responsibilities

 

Candidate must have knowledge and experience of appropriate GCP compliance and other applicable regulations and laws. Demonstrated capabilities to assist QA management in the implementation of systems and perform GCP audits in accordance with AGENUS processes.   To exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information. 

  • Schedule, prepare and conduct audits in support of GCP as directed.
  • Assemble and coordinate the activities of the audit team
  • Review and, if necessary, identify improvements that enhance the quality and clarity of audit reports.
  • Assist QA management in the development and implementation of procedures and working practices to ensure continuous quality improvement.
  • Plan, track and oversee GCP and GcLP audits of external contract laboratories and contract research organizations.
  • Plan track and oversee GCP and GcLP internal audits against approved procedures.
  • Ensure compliance of clinical operations and initiatives with all applicable regulations and standards.
  • Partner with Clinical Operations to oversee all appropriate clinical activities, review all audit reports and corrective actions generated from the audits.
  • Work with internal GCP Clinical Operations stakeholders and develop and execute strategic audit plans for the area.
  • Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations.
  • Exercises judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance.
  • Appropriately escalate any compliance risks to management.
  • Contribute to the information provided to QA management to summarize quality issues arising from audits and other related activities, as requested.
  • Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and provide assessment of the impact of any deficiencies.
  • Ensure review of clinical study reports, external publications, etc.
  • Maintain relevant knowledge of both local and international auditing and appropriate GxP requirements and developments as they impact AGENUS’s SOPs and compliance with GxP, and communicate these to the QA team and QA management, as applicable.

Qualifications

  • Bachelors degree required.
  • 3+ years of direct audit experience in GCP required
  • Knowledge of US FDA regulations, International Conference on Harmonization (ICH) and EU GCP regulations and guidelines is required.

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