Quality Assurance Specialist

Mar 27, 2023
Apr 12, 2023
Full Time
Quality Assurance Specialist

EMMES Services Pvt. Ltd, Bangalore, a fully owned subsidiary of The Emmes Company, LLC. Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over one thousand 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.


Emmes Services Pvt. Ltd , ("Emmes") is searching for QA Specialist in our India office to support computer validation and information security audits. Emmes provides flexibility for office location preference, dependent upon position. The QA Specialist will provide direct support to Emmes' proprietary software systems, commercial off-the-shelf software (COTS) used on clinical trials, as well as Information Technology Security deliverables. This individual will be responsible for auditing verification and validation (V&V) activities, developing and implementing V&V processes for both in-house built software and COTS software, and documentation of these activities. The QA Specialist will also assist in the conduct of internal audits specific to Emmes' Information Technology and Information Security processes and controls to comply with Good Clinical Practice (GCP) requirements, National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, US Federal Information Security Management Act (FISMA), 21 CFR Part 11 / Annex 11 requirements, internal SOPs, and industry standards.

This position is in India and may work remotely, with travel required to support audits and inspections.

Primary Responsibilities
  • Develop and implement information security and computer systems verification and validation processes
  • Perform audits, reviews, and inspections of software and program activities for proprietary and purchased software
  • Conduct periodic assessment of information security controls
  • Review scan and evidence controls provided by Information Technology department
  • Ensure remediation activities from FISMA audits are completed
  • Ensure identified vulnerabilities are appropriately remediated in specified timeframe
  • Ensure items documented on the plans of action and milestones (POAM) are addressed per NIST SP 800-53
  • Provide input regarding Emmes' risk register
  • Audit proprietary software for potential security gaps and non-compliance
  • Support vendor qualification and evaluation activities for software related vendors
  • Support regulatory/client audits and inspections, as needed
  • Other duties as assigned

  • BS degree in computer science, software engineering, or a related field, and two to five years of experience in computer systems and / or information technology security auditing
  • Familiarity was SAST and DAST tools and their use in identifying security vulnerabilities
  • One to three years' experience auditing validation processes preferred
  • Experience in a GCP environment a plus
  • 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 and travel to Emmes offices

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