Job Details

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