The Emmes Company, LLC is seeking a QA Specialist - Computer System Validation
based out of our Rockville, MD, Frederick, MD, or Tysons, VA offices to support all phases of clinical trials. Emmes provides flexibility for the office location or remote work preference dependent upon position.
The Emmes Company, LLC established in 1977, is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, 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. Primary Purpose
The QA Specialist - CSV will provide direct support to Emmes' proprietary software systems and commercial off-the-shelf software (COTS) used on clinical trials. The Specialist will be responsible for auditing verification and validation (V&V) activities, processes, in-house built software, and documentation. The Specialist will also assist in the conduct of internal audits and in various quality improvement initiatives in order to comply with Good Clinical Practice (GCP) requirements, Good Documentation Practice (GDP), 21 CFR Part 11 / Annex 11 requirements, internal SOPs, and industry standards. Primary Responsibilities
- Perform audits, reviews, and inspections of software and program activities for proprietary and purchased software
- Inspect proprietary software for potential security gaps and non-compliance
- Provide consultation to Emmes staff regarding validation best practices
- Develop and deliver relevant training content to staff, as needed
- Support/lead quality and standardization initiatives related to Emmes' validation processes
- Participate in change control processes
- Support vendor qualification and evaluation activities
- Support regulatory/client audits and inspections
- Write/revise SOPs, as needed
CONNECT WITH US!!
- BS degree in computer science, software engineering, or a related field, or equivalent years of experience in computer systems auditing and quality assurance
- Familiarity was SAST and DAST tools and their use in identifying security vulnerabilities
- Experience in healthcare of clinical studies highly preferred
- One to three years' experience auditing validation processes required
- Experience in a GCP environment a plus
- Certified Quality Auditor, ISO Lead Auditor, or equivalent certification recommended
- Strong written and oral communication skills
- Ability to work with others as well as independently
- Ability to multi-task
- Excellent organizational skills
- Enjoy working in a team environment
- Required Travel: Up to 25% to conduct vendor audits
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The Emmes Company, LLC 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.