Quality Assurance Auditor -GLP - United States
Our company is a leading global contract research organization, seeks a Quality Assurance Auditor to support our Bioanalytical department.
The successful candidate will have quality assurance expertise within a GLP environment.
Role: The role of the Quality Assurance Auditor is to assess and assure study, project and process compliance with protocols, Controlled documents, and applicable regulations and guidelines through audits.
- Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections.
- Perform in-process inspections of study phases and methods; report audit findings to operations via QA audit reports; determine acceptability of the responses and verify the corrections.
- Review study events, deviations, investigations, and change control documentation; and assess acceptability of the content and documentation.
- Maintain QA files and QA audit reports.
- Interact with internal and external clients to discuss QA observations and study related issues; and maintain effective and professional working relationships within and across departments in relation to study projects.
- Perform other functions as assigned by Quality Assurance Management.
- Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes.
- Detect Quality Issues and the need for CAPAs and assist Quality Assurance Management with the QI/CAPA process
- Assist with the preparation for and hosting of client audits and/or regulatory inspections.
- Participate in the preparation, execution and follow up for System Audits and Vendor Audits.
Education and Qualifications:
- Bachelor’s degree in science, IT, business, or similar
- 2-5 years quality/ functional ops/ GLP experience
- Working knowledge of applicable regulations and guidance documents (GLP/GCP/E-records & E-signatures)
- Excellent oral and written communication skills
- Ability to organize and manage multiple priorities
- Excellent time management skills
- Attention to detail, tactful, and diplomatic
- Proficiency with Microsoft Office and general computer knowledge
- In addition to providing clinical pharmacology and early clinical research services in North America and Europe, our company operates two bio-analytical laboratories where the latest analytical technologies are leveraged to provide quantitative measures of drug, metabolite and biomarkers in samples collected from humans participating in research studies.
- With over 750 employees and over 40 years of experience conducting early clinical research, our company is the provider of choice for many of the world’s leading pharmaceutical companies.
- In addition, our company scientists bring a depth of experience in drug development that is proving important for growing businesses in Asia and other parts of the world.