Clinical Quality Assurance Specialist

Location
Rockville, Maryland
Salary
Competitive
Posted
Sep 04, 2020
Closes
Oct 03, 2020
Ref
2625
Function
Other
Industry
Science
Hours
Full Time
The Emmes Company, LLC is seeking a Clinical Quality Assurance Specialist 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 work remote 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. Emmes is seeking a QA Specialist in our Rockville, MD, Frederick, MD, or Tysons, VA offices to support all phases of clinical trials.

Primary Purpose

The QA Specialist 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, department, processes, and vendors used to support clinical trials. He/she will be responsible for assisting in various quality improvement initiatives in order to comply with Good Clinical Practice (GCP) and ICH requirements, SOPs, and applicable regulations. This individual will work closely with a Quality Assurance Manager in support of Emmes' corporate Quality Assurance Department.

Primary Responsibilities
  • Conduct internal audits to identify non-compliance in adherence to SOPs and regulations
  • Provide GCP/QA consultation to Emmes staff
  • Support regulatory/client audits
  • Support supplier/vendor qualification and evaluation
  • Support / lead quality and standardization initiatives
  • Drive completion of quality compliance plans
  • Write/revise SOPs, as needed
  • Prepare Quality Management Reports
  • Support quality improvement initiatives in order to comply with Good Clinical Practice (GCP) requirements, SOPs, applicable regulations, and promote quality

Requirements
  • BS degree and 2 years GxP industry experience
  • Experience with GxP auditing activities
  • Certified Quality Auditor (ASQ-CQA, RQAP-GCP), ISO, CCRA, or equivalent certification recommended
  • Knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines preferred
  • Strong written and oral communication skills
  • Ability to work with others as well as independently
  • Ability to multi-task
  • Excellent organizational and time management skills
  • Enjoy working in a team environment
  • Required Travel: Up to 25% to conduct supplier/vendor audits
  • Remote staff may be required to work from the Rockville, MD location to support third party regulatory inspections and client 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.

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