Quality Assurance Auditor
Posted on Nov 16, 2018 by EMMES Corporation
The Emmes Corporation, established in 1977, is a privately-owned Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
The Quality Assurance Auditor will assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations by conducting audits of Emmes projects, departments, processes, and vendors used to support clinical trials. The auditor will provide direct support to Emmes projects by providing good documentation practice (GDP) consultation on sponsor and regulatory deliverables. The auditor will also be responsible for conducting audits on Emmes-owned trial master file (TMF) documents, or documents Emmes provides to sponsors for inclusion in a trial master file. The auditor will also assist in the conduct of project audits and in various quality improvement initiatives in order to comply with Good Clinical Practice (GCP) requirements, GDPs, internal SOPs, industry standards, and applicable regulations.
- Conduct audits of TMF documents (both paper and electronic) and report audit results to QA and project management staff
- Develop TMF audit plans and contribute to TMF audit SOPs, as appropriate
- Assist the regulatory and project teams in quality maintenance of essential clinical trial documents
- Provide GDP training to project staff, as needed
- Provide direct GCP/QA consultation to Emmes staff regarding deliverables to sponsors and regulatory agencies
- Support/lead quality and standardization initiatives
- Conduct audits to identify non-compliance to SOPs, regulations, and GCPs
- Review Quality Records for accuracy and compliance (Compliance with SOPs, GDPs, training records, CAPAs, audit reports)
- Write/revise SOPs, as needed
- Support supplier/vendor qualification and evaluation
- Support regulatory/client audits
- Bachelor's degree in a scientific discipline is required with at least 1 year of experience reviewing / auditing / performing QC activities of trial master files (paper and electronic); in lieu of a degree the combination of experience and training in clinical trial auditing and quality assurance will be taken under consideration.
- An in-depth knowledge and experience in the application of good clinical practice (GCP) requirements is required (e.g., ICH, FDA, etc.), as is familiarity with the essential documents related to clinical studies
- Experience in GCP auditing activities
- Thorough knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines
- Strong written and oral communication skills
- Ability to work in a team environment as well as independently
- Excellent organizational skills with the ability to multi-task
- Certified Quality Auditor, ISO, CCRA, or equivalent certification recommended
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The EMMES Corporation is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.