QA Auditor (GLP/ GCP)

Responsibilities

(QA Auditor I, II, III)

· Audit documents against regulatory requirements; GLP, GCP, EPA, OECD, 21CFR Part 11

· Verify lab tasks are performed in accordance to Good Documentation Practices (GDP)

· Audit laboratory documents and notebooks (e.g. plans, experiment/sample runs, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations

· Audit data files and reports

· Audit computer systems, facility operations, and other non-study regulated activities

· Assist with maintaining Master Schedule

· Identify non-compliance, deviations, and Quality events and assist with resolution

· Escalate data integrity and non-compliance issues to Management

· Follow applicable SOPs and procedural documents

· Assist with template and SOP review

· Participate in client audits as needed

· Enforce lab SOPs and requirements

· Review system audit trails

· Other tasks as assigned

(QA Auditor II and III)

· Conduct quality training as needed

· Track and present quality metrics

· Perform vender qualifications and audits

· Train and mentor lower level Auditors

· Review and evaluate procedures to improve quality and efficiency

· Participate in CAPAs and investigations as needed

· Review and author templates and SOPs

· Other tasks as assigned

Skills, Education & Qualifications

· BA/BS or higher; all experiences will be evaluated

· 1-7 years experience in GxP Environment, all experiences will be evaluated

· Knowledge of regulatory requirements; GLP, GCP, EPA, OECD, 21CRF Part 11, GDP

· Familiar with pharmaceutical or biotechnology industry

· Able to review detailed data and documents

· Able to work effectively and contribute within a team

· Able to work with computer systems

· Able to document and communicate clearly; Ability to multitask and to perform & learn in a fast-paced environment